Cleared Traditional

K801031 - BLADE SEPTOSTOMY CATHETER

K801031 is an FDA 510(k) clearance for BLADE SEPTOSTOMY CATHETER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DXF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K801031 · Cook, Inc. · Cardiovascular device
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Jul 1980
Decision
88d
Days
Class 2
Risk

K801031 is an FDA 510(k) clearance for the BLADE SEPTOSTOMY CATHETER. Classified as Catheter, Septostomy (product code DXF), Class II - Special Controls.

Submitted by Cook, Inc. (Walker, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5175 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook, Inc. devices

FDA 510(k) Submission Details - K801031

510(k) Number K801031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1980
Decision Date July 28, 1980
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXF Device Classification - Class 2, Special Controls

Product Code DXF Catheter, Septostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5175
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.