CATHLAB SILICONE OCCLUSION BALLOON CATHETER— 510(k) K910916

Name: FDA 510(k) clearance K910916
Creator: U.S. Food and Drug Administration
Published: 1991-06-24

Substantially Equivalent

Cathlab Corp.

FDA 510(k) clearance K910916 for CATHLAB SILICONE OCCLUSION BALLOON CATHETER, Substantially Equivalent on 1991-06-24. Applicant: Cathlab Corp.. Device class: 2.

Clearance details

Applicant: Cathlab Corp.
Product code: Code DQT
Device class: Class 2
Regulation: 21 CFR 870.1370
Advisory panel: Cardiovascular
Date received: 1991-03-05
Decision date: 1991-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K880231 — MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER1988-05-25

More clearances from Cathlab Corp.

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K910917 — CATHLAB SILICONE BILIARY BALLOON CATHETER1991-08-02
K905139 — CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER1991-02-25
K897051 — MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH1990-03-16
K897184 — 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS1990-03-14
K893435 — SILICONE FLOW-DIRECTED THERMODILUTION CATHETER1989-09-26

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