Chrysalis Intelligence · Product Codes · LOX

LOX · Unclassified

26 clearances · 17 unique sponsors

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Device class
—
Regulation —
Total clearances
26
2020-03-04 → 2026-08-14
Last 12 months
6
Unique sponsors
17
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Medtronic, Ireland 3 3 2026-08-14
OrbusNeich Medical (Shenzhen) Co., Ltd. 3 0 2024-08-16
Brosmed Medical Co., Ltd. 2 0 2023-04-11
Sino Medical Sciences Technology, Inc. 2 0 2023-02-15
Kossel Medtech (Suzhou) Co., Ltd. 2 0 2022-01-07
Shanghai MicroPort Medical (Group) Co., Ltd. 2 1 2026-04-07
Medcaptain Life Science Co., Ltd. 2 0 2021-05-06
Orbusneich Medical Trading, Inc. 1 0 2020-03-04
Biotronik, Inc. 1 0 2024-10-25
Verge Medical, Inc. 1 1 2026-04-02
Dongguan TT Medical, Inc. 1 0 2023-06-29
Abbott Vascular 1 0 2022-06-30
Boston Scientific 1 0 2022-03-24
Terumo Corporation 1 1 2026-03-27
Sis Medical AG 1 0 2022-03-14
Vascular Solutions, LLC 1 0 2024-05-31
Natec Medical , Ltd. 1 0 2021-07-09
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
92982 CPT — High Percutaneous transluminal coronary angioplasty; standard PTCA catheter use
C1725 HCPCS Catheter, transluminal angioplasty, non-laser (may include guidance, infusion/perfusion capability) ✓ CMS-verified description High Catheter, transluminal angioplasty; device-specific supply code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-14 K261428 Medtronic Ireland NC Euphora Rapid Exchange Balloon Dilatation Catheter
2026-07-27 K261759 Medtronic Ireland Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
2026-04-07 K252116 Shanghai MicroPort Medical (Group) Co., Ltd. Firefighter™ Pro PTCA Balloon Catheter
2026-04-02 K254022 Verge Medical, Inc. FLASH Flex™ Aorto-Ostial Angioplasty System
2026-03-27 K252295 Terumo Corporation Ryurei
2026-01-17 K251970 Medtronic, Ireland Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
2024-10-25 K242969 Biotronik, Inc. Pantera Pro; Pantera LEO
2024-08-16 K233499 OrbusNeich Medical (Shenzhen) Co., Ltd. Sapphire NC ULTRA Coronary Dilatation Catheter
2024-08-15 K233505 OrbusNeich Medical (Shenzhen) Co., Ltd. Sapphire ULTRA Coronary Dilatation Catheter
2024-05-31 K233729 Vascular Solutions, LLC Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58
2023-07-21 K223189 Shanghai MicroPort Medical (Group) Co., Ltd. Firefighter™ NC Pro PTCA Balloon Catheter
2023-06-29 K230374 Dongguan TT Medical, Inc. Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)
2023-04-11 K230705 Brosmed Medical Co., Ltd. POT PTCA Balloon Dilatation Catheter
2023-02-15 K223022 Sino Medical Sciences Technology, Inc. SC HONKYTONK PTCA Balloon Dilatation Catheter
2022-12-21 K222538 Sino Medical Sciences Technology, Inc. NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
2022-06-30 K220634 Abbott Vascular NC TREK NEO Coronary Dilatation Catheter
2022-03-24 K220629 Boston Scientific Emerge Monorail PTCA Dilatation Catheter
2022-03-14 K212393 Sis Medical AG OPN NC PTCA Dilatation Catheter
2022-01-07 K211349 Kossel Medtech (Suzhou) Co., Ltd. Selebrek PTCA Balloon Dilatation Catheter
2021-10-14 K211807 OrbusNeich Medical (Shenzhen) Co., Ltd. Sapphire NC 24
2021-07-09 K210012 Natec Medical , Ltd. Tamarin Blue PTCA RX Dilatation Catheter
2021-07-02 K211393 Kossel Medtech (Suzhou) Co., Ltd. Selethru(TM) NC PTCA Balloon Dilatation Catheter
2021-05-06 K202578 Medcaptain Life Science Co., Ltd. KardiFlex NC Coronary Dilatation Catheter
2021-04-29 K202619 Medcaptain Life Science Co., Ltd. KardiFlex PTCA Balloon Dilatation Catheter
2021-04-14 K203390 Brosmed Medical Co., Ltd. Artimes pro Balloon Dilatation Catheter
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence