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Revolution Peripheral Atherectomy System 2006200166

by Rex Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857141005391 UDI-DI Date16 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Revolution Peripheral Atherectomy System
Generic Name
Mechanical atherectomy system catheter, peripheral
Model / Ref / Catalog
2006200166
Primary DI / UDI-DI
00857141005391
510(k) Number
FDA Product Code
MCW
GMDN Term
Mechanical atherectomy system catheter, peripheral
Device Class
Class II
Regulation Number
870.4875
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K212351)

Other devices from Rex Medical, Inc.

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No