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enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wire EV-4537-F2RR-1

by Vesalio, 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 Number00850083646042 UDI-DI Date20 Mar 2026ListedStatusListed 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  • Withdrawn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
enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wire
Generic Name
Thrombectomy wire-net
Model / Ref / Catalog
EV-4537-F2RR-1
Primary DI / UDI-DI
00850083646042
510(k) Number
FDA Product Code
QEX, QEW, KRA
GMDN Term
Thrombectomy wire-net
Device Class
Class II
Regulation Number
870.5150, 870.1210
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K253407)

Other devices from Vesalio, Inc.

See all devices from Vesalio, Inc. →

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