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Cartouch

by Cardionics, Inc.

510(k) K002197

Cartouch is a Class II device made by Cardionics, Inc., cleared under FDA 510(k) K002197 on 27 Dec 2000, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK002197 Date27 Dec 2000ClearedStatusActive

Official records

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  • Withdrawn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
DPS
Device class
Class II
Regulation
21 CFR Part 870.2340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Other devices from Cardionics, Inc.