CPR HEART PACK— 510(k) K960209

Name: FDA 510(k) clearance K960209
Creator: U.S. Food and Drug Administration
Published: 1996-04-04

Substantially Equivalent

Custom Pack Reliability

FDA 510(k) clearance K960209 for CPR HEART PACK, Substantially Equivalent on 1996-04-04. Applicant: Custom Pack Reliability. Device class: 2.

Clearance details

Applicant: Custom Pack Reliability
Product code: Product code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 1996-01-16
Decision date: 1996-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

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K960205 — CPR TRACHEOTOMY CARE TRAY1996-08-27
K960239 — CPR D & C TRAY1996-05-23
K960243 — CPR C-SECTION DELIVERY PACK1996-05-23
K960216 — CPR SUCTION CATHETER KIT1996-04-15
K960206 — CPR DRESSING CHANGE TRAY1996-04-12

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.