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Firmap Catheter

by Topera, Inc.

510(k) K130827

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130827 Date31 Oct 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2478-2015 FDA Class III initiated 12 Aug 2015

    The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.

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  • Withdrawn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
MTD
Device Class
Class II
Regulation
21 CFR Part 870.1220
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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