FOLEY CATHETER INSERTION TRAY (10CC)— 510(k) K901185

Unknown

Orion Life Systems, Inc.

FDA 510(k) clearance K901185 for FOLEY CATHETER INSERTION TRAY (10CC), Unknown on 1990-07-20. Applicant: Orion Life Systems, Inc.. Device class: 2.

Clearance details

Applicant: Orion Life Systems, Inc.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-13
Decision date: 1990-07-20
Decision: Unknown
Clearance type: Traditional
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Orion Life Systems, Inc.

K943835 — PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID1995-01-24
K943828 — STERILE WATER FOR IRRIGATION1994-11-21
K943829 — PRE-FILLED SYSRINGE W/STERILE WATER1994-11-21
K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION1994-11-21
K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER1994-11-21

Recalls naming K901185

K-number listed on FDA's recall record

Z-2154-2014 — RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.Class III·Terminated·Teleflex Medical·20140710

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K901185.

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