PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)— 510(k) K021864

Name: FDA 510(k) clearance K021864
Creator: U.S. Food and Drug Administration
Published: 2002-09-23

Substantially Equivalent

Primeline Medical Products, Inc.

FDA 510(k) clearance K021864 for PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142), Substantially Equivalent on 2002-09-23. Applicant: Primeline Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Primeline Medical Products, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2002-06-06
Decision date: 2002-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edmonton, Alberta, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Primeline Medical Products, Inc.

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K022868 — PRIMAGARD SURGICAL EQUIPMENT DRAPES2002-11-08
K023117 — PRIMAGARD SURGICAL GOWNS2002-11-08
K023266 — PRIMAGARD SURGICAL GOWNS2002-11-08
K021076 — PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM2002-04-16
K011789 — PROCEDURE MASKS: PM4-301 AND PM4-3042001-06-22

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