Cleared Traditional

K950855 - ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS

K950855 is an FDA 510(k) clearance for ASE MAXI-TORQUE, manufactured by Adam Spence Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K950855 · Adam Spence Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
92d
Days
Class 2
Risk

K950855 is an FDA 510(k) clearance for the ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Adam Spence Corp. (Wall, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Adam Spence Corp. devices

FDA 510(k) Submission Details - K950855

510(k) Number K950855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1995
Decision Date May 30, 1995
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 392
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K950855.
TRANSIT-2 INFUSION CATHETER
K950910 · Cordis Neurovascular, Inc. · Aug 1995
SCIMED EXPO ANGIOGRAPHIC CATHETER
K951720 · Scimed Life Systems, Inc. · Jun 1995
0.035 IN. WISE WIRE
K942927 · Boston Scientific Corp · Jun 1995
TRANSIT-2 INFUSION CATHETER
K950909 · Cordis Neurovascular, Inc. · May 1995
SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER
K950731 · Scimed Life Systems, Inc. · Apr 1995
CONTROL
K944284 · Daig Corp. · Mar 1995