Cleared Traditional

K896520 - OWENS CATHETER

K896520 is the FDA 510(k) clearance for OWENS CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 495-day FDA review.

K896520 · Boston Scientific Corp · Cardiovascular device
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Mar 1991
Decision
495d
Days
Class 2
Risk

K896520 is an FDA 510(k) clearance for the OWENS CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on March 25, 1991 after a review of 495 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: 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 Cardiovascular submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K896520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1989
Decision Date March 25, 1991
Days to Decision 495 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
370d slower than avg
Panel avg: 125d · This submission: 495d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 238
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