CUSTOMED CARDIOVASCULAR PACK— 510(k) K904693

Clearance details

Applicant

Customed, Inc.

Product code

Code KKX

Device class

Class 2

Regulation

21 CFR 878.4370

Advisory panel

General, Plastic Surgery

Date received

1990-10-16

Decision date

1991-01-02

Decision

Unknown

Clearance type

Traditional

Location

Carolina Puerto Rico, US

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• Z-2580-2015 — PEDIATRIC LAP PACK 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .Class II·Terminated·Customed, Inc·20150710
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• Z-2582-2015 — PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .Class II·Terminated·Customed, Inc·20150710
• Z-2602-2015 — OPEN HEART TRAY CUSTOMED 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .Class II·Terminated·Customed, Inc·20150710
• Z-2649-2015 — OPEN HEART PACK 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .Class II·Terminated·Customed, Inc·20150710

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904693.