CUSTOMED ANGIODRAPE PACK FEMORAL— 510(k) K904694

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-1431-2016 — Catalog Number: 900164 FEMORAL SURGICAL PACK 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·20160107
• Z-1442-2016 — Catalog Number: 9002164 FEMORAL SURGICAL PACK 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·20160107
• Z-2548-2015 — ANGIODRAPE PK 4/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-2588-2015 — ANGIOGRAPHY PK 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-2598-2015 — FEMORAL 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-2622-2015 — ANGIOGRAPHY PACK CUSTOMED 4/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-2623-2015 — KNEE ARTHROSCOPY PK 4/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-2624-2015 — FEMORAL PACK 4/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-2671-2015 — ANGIODRAPE PACK DAMAS 6/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-2691-2015 — ANGIOGRAPHY 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-2704-2015 — GENERAL MINOR PK 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

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904694.