Chrysalis Intelligence · Product Codes · DRE

DRE · Dilator, Vessel, For Percutaneous Catheterization

Cardiovascular · 14 clearances · 8 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Device class
Class II
Regulation 870.1310
Total clearances
14
2020-03-19 → 2026-07-27
Last 12 months
2
Unique sponsors
8
Classification details
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.1310
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Baylis Medical Company, Inc. 4 0 2025-05-29
Merit Medical Systems, Inc. 3 1 2026-07-27
Spectranetics, Inc. 2 0 2022-12-15
Togo Medikit Co., Ltd. 1 0 2020-03-19
Xcardia Innovation , Ltd. 1 0 2022-02-17
Sorin Group Italia S.R.L. 1 1 2025-12-19
Medron, LLC 1 0 2020-05-06
Cook Incorporated 1 0 2021-04-06
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
36568 CPT — Medium Vessel dilator typically bundled into percutaneous catheterization procedure codes
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-27 K261310 Merit Medical Systems, Inc. FlexTract Deflectable-Rotational Dilator Sheath Set
2025-12-19 K253616 Sorin Group Italia S.R.L. ProtekDilate Vascular Access Kit
2025-05-29 K251325 Baylis Medical Company, Inc. VersaCross Connect™ Transseptal Dilator
2025-01-15 K242229 Merit Medical Systems, Inc. Micro Ace Gold Advanced Micro Access System
2024-07-12 K241720 Baylis Medical Company, Inc. VersaCross Connect™ Transseptal Dilator
2023-12-14 K233647 Baylis Medical Company, Inc. VersaCross Connect™ Transseptal Dilator
2023-09-27 K232609 Merit Medical Systems, Inc. Micro Ace™ Advanced Micro Access System
2022-12-15 K223472 Spectranetics, Inc. TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
2022-08-24 K212784 Spectranetics, Inc. TightRail Guardian Motorized Dilator Sheath
2022-02-17 K211679 Xcardia Innovation , Ltd. Xtractor device
2021-04-06 K210734 Cook Incorporated Endovascular Dilator and Sets
2020-06-12 K201288 Baylis Medical Company, Inc. ExpanSure Large Access Transseptal Dilator
2020-05-06 K192283 Medron, LLC MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
2020-03-19 K200379 Togo Medikit Co., Ltd. Super Sheath
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence