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OWQ · Reprocessed Intravascular Ultrasound Catheter

Cardiovascular · 16 clearances · 8 unique sponsors

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Device class

Class II

Regulation 870.1200

Total clearances

16

2020-11-20 → 2026-06-29

Last 12 months

1

Unique sponsors

8

Definition

What is Reprocessed Intravascular Ultrasound Catheter

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

Classification details

Medical specialty

Cardiovascular

Review panel

CV

Regulation number

870.1200

Implant

N

Life-sustain / support

N

GMP exempt

N

Third-party review

N

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
ABBOTT MEDICAL	3	0	2023-06-30
Vein 360, LLC	3	0	2023-10-24
Surgical Instrument Service and Savings, Inc.	3	0	2025-06-05
Innovative Health, LLC	2	0	2022-05-25
Northeast Scientific, Inc.	2	0	2025-05-12
Stryker Sustainability Solutions	1	0	2023-07-25
Surgical Instrument Services and Savings, Inc.	1	0	2023-12-15
Sterilmed, Inc.	1	1	2026-06-29

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.

Code	Type	Description	Confidence	Rationale
92978	CPT	—	High	Intravascular ultrasound (IVUS) imaging during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-29	K254149	Sterilmed, Inc.	Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)
2025-06-05	K250545	Surgical Instrument Service and Savings, Inc.	Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
2025-05-12	K250592	Northeast Scientific, Inc.	NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
2025-03-10	K243101	Surgical Instrument Service and Savings, Inc.	Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)
2024-09-10	K234064	Surgical Instrument Service and Savings, Inc.	Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
2023-12-15	K232130	Surgical Instrument Services and Savings, Inc.	Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
2023-10-24	K232584	Vein 360, LLC	Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
2023-08-25	K230928	Vein 360, LLC	Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
2023-07-25	K231621	Stryker Sustainability Solutions	Reprocessed ViewFlex Xtra ICE Catheter (D087031)
2023-06-30	K231588	ABBOTT MEDICAL	ViewFlex Eco Reprocessed ICE Catheter
2023-06-06	K230584	Vein 360, LLC	Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
2023-05-03	K230934	ABBOTT MEDICAL	ViewFlex Eco Reprocessed ICE Catheter
2023-02-03	K223026	Northeast Scientific, Inc.	NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
2022-12-19	K222217	ABBOTT MEDICAL	ViewFlex Xtra Reprocessed ICE Catheter
2022-05-25	K210655	Innovative Health, LLC	Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
2020-11-20	K202042	Innovative Health, LLC	Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter