Cleared Traditional

K934685 - SOFTTOUCH GUIDE CATHETER

K934685 is an FDA 510(k) clearance for SOFTTOUCH GUIDE CATHETER, manufactured by Mallinckrodt Medical. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K934685 · Mallinckrodt Medical · Cardiovascular device
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Apr 1994
Decision
189d
Days
Class 2
Risk

K934685 is an FDA 510(k) clearance for the SOFTTOUCH GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on April 7, 1994 after a review of 189 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Mallinckrodt Medical devices

FDA 510(k) Submission Details - K934685

510(k) Number K934685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1993
Decision Date April 07, 1994
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
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 824
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K934685.
ACS POWERBASE(TM) CORONARY GUIDING CATHETER
K940559 · Advanced Cardiovascular Systems, Inc. · May 1994
METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS
K935425 · Medtronics Interventional Vascular · Apr 1994
SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER
K940603 · Scimed Life Systems, Inc. · Apr 1994
ENVOY GUIDING CATHETER
K940187 · Cordis Neurovascular, Inc. · Mar 1994
GUIDING CATHETER
K930476 · Boston Scientific Corp · Feb 1994
GC IV CORONARY GUIDING CATHETER
K932933 · Medtronics Interventional Vascular · Feb 1994