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Seismiq™ Fg-006919

by Bolt Medical, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850056723077 UDI-DIDate31 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Seismiq™
Generic Name
Intravascular lithotripsy system catheter, balloon, peripheral
Model / Ref / Catalog
FG-006919
Primary DI / UDI-DI
00850056723077
FDA Product Code
PPN
GMDN Term
Intravascular lithotripsy system catheter, balloon, peripheral
Device Class
Class II
Regulation Number
870.1250
GUDID distribution status
In Commercial Distribution
Size
Balloon Length — 60 Millimeter
Balloon Diameter — 7 Millimeter

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Properties

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

Other properties (9)

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