Cleared Traditional

K930476 - GUIDING CATHETER

K930476 is the FDA 510(k) clearance for GUIDING CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K930476 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
377d
Days
Class 2
Risk

K930476 is an FDA 510(k) clearance for the GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on February 10, 1994 after a review of 377 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 Boston Scientific Corp devices

Submission Details

510(k) Number K930476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1993
Decision Date February 10, 1994
Days to Decision 377 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
252d slower than avg
Panel avg: 125d · This submission: 377d
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 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K930476.
SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER
K940603 · Scimed Life Systems, Inc. · Apr 1994
SOFTTOUCH GUIDE CATHETER
K934685 · Mallinckrodt Medical · Apr 1994
ENVOY GUIDING CATHETER
K940187 · Cordis Neurovascular, Inc. · Mar 1994
9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER
K934988 · Scimed Life Systems, Inc. · Jan 1994
ACS POWERGUIDE CORONARY GUIDING CATHETER
K934009 · Advanced Cardiovascular Systems, Inc. · Jan 1994
USCI SUPER 6 6F PTCA GUIDING CATHETER
K933019 · C.R. Bard, Inc. · Sep 1993