Cleared Traditional

K772011 - WHOLEY OCCLUSION BALLOON CATHETER

K772011 is the FDA 510(k) clearance for WHOLEY OCCLUSION BALLOON CATHETER by Cook, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 598-day FDA review.

K772011 · Cook, Inc. · General Hospital
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Jun 1979
Decision
598d
Days
Class 2
Risk

K772011 is an FDA 510(k) clearance for the WHOLEY OCCLUSION BALLOON CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Cook, Inc. (Walker, US). The FDA issued a Cleared decision on June 15, 1979 after a review of 598 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Cook, Inc. devices

Submission Details

510(k) Number K772011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1977
Decision Date June 15, 1979
Days to Decision 598 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
469d slower than avg
Panel avg: 129d · This submission: 598d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 240
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K772011.
ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
K801414 · G.D. Searle and Co. · Aug 1980
INJECTION SITE, CODE NO. 3100
K800786 · Quest Medical, Inc. · May 1980
MEDICAL COMPONENTS IV CATHETER
K800525 · Medical Components, Inc. · Apr 1980
I.V. START KIT
K780350 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978
NEEDLE CONNECTING SET, BLUNT
K780105 · Abbott Laboratories · Feb 1978
CATHETERS, OVER-THE-NEEDLE
K770751 · Cutter Laboratories, Inc. · May 1977