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Cardio Clear PZ300

by Cardio-Medical Products, Inc.

Cardio Clear PZ300 is a Class II device made by Cardio-Medical Products, Inc., cleared under FDA 510(k) K103651 on 4 Oct 2011 and listed in FDA GUDID since 28 Jul 2015 (UDI-DI 00814907020326), active as of 8 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

510(k) K103651

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814907020326 UDI-DI Date28 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103651 Date4 Oct 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103651 decided 4 Oct 2011 Active
  • FDA GUDID UDI-DI 00814907020326 listed 28 Jul 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103651
  2. Listed FDA GUDID 00814907020326

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cardio Clear
Generic name
External defibrillation electrode, paediatric, single-use
Model / Ref / Catalog
PZ300
Primary DI / UDI-DI
00814907020326
510(k) Number
FDA product code
LDD
GMDN term
External defibrillation electrode, paediatric, single-use
Device class
Class II
Regulation number
870.5300
GUDID distribution status
In Commercial Distribution

Related devices

Category: External defibrillation electrode, paediatric, single-use

Cleared under the same submission (K103651)

Similar devices

Other devices filed under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)).

Other devices from Cardio-Medical Products, Inc.

See all devices from Cardio-Medical Products, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)