Cleared Traditional

K851241 - GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851241 · Cook, Inc. · Cardiovascular device
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Feb 1986
Decision
365d
Days
Class 2
Risk

K851241 is an FDA 510(k) clearance for the GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cook, Inc. (New Brunswick, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

Submission Details

510(k) Number K851241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date February 26, 1986
Days to Decision 365 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
240d slower than avg
Panel avg: 125d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 887
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