Cleared Traditional

K021735 - BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON...

K021735 is the FDA 510(k) clearance for BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON... by Boston Scientific Scimed, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K021735 · Boston Scientific Scimed, Inc. · Cardiovascular device
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Aug 2002
Decision
72d
Days
Class 2
Risk

K021735 is an FDA 510(k) clearance for the BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 8, 2002 after a review of 72 days - a notably fast clearance cycle.

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: 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 Boston Scientific Scimed, Inc. devices

Submission Details

510(k) Number K021735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2002
Decision Date August 08, 2002
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
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 577
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K021735.
PTA AND PTV
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K021455 · Guidant Corp. · Aug 2002
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K021899 · Concentric Medical, Inc. · Jul 2002
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K021721 · Boston Scientific Corp · Jun 2002