Cleared Traditional

K930476 - GUIDING CATHETER

K930476 is an FDA 510(k) clearance for GUIDING CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K930476

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.

DQY Device Classification - Class 2, Special Controls

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 780
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
GC IV CORONARY GUIDING CATHETER
K932933 · Medtronics Interventional Vascular · Feb 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