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Prestige Coil System

by Bait USA, LLC

510(k) K220699

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK220699 Date8 Apr 2022ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1989-2025 FDA Class II initiated 8 May 2025

    Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

    • Ongoing Z-1042-2024 FDA Class II initiated 3 Jan 2024

    Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KRD
Device Class
Class II
Regulation
21 CFR Part 870.3300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent