Cleared Traditional

MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER (K963092) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963092 · Adam Spencer Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
158d
Days
Class 2
Risk

K963092 is an FDA 510(k) clearance for the MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Adam Spencer Corp. (Miami, US). The FDA issued a Cleared decision on January 13, 1997 after a review of 158 days - an extended review cycle.

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 Spencer Corp. devices

Submission Details

510(k) Number K963092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1996
Decision Date January 13, 1997
Days to Decision 158 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 slower than avg
Panel avg: 125d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 145
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K963092.
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
K971607 · Boston Scientific Corp · Jul 1997
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER
K971646 · Cordis Corp. · Jul 1997
USCI MAINSTAY GUIDING CATHETER
K971034 · C.R. Bard, Inc. · May 1997
USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC
K960056 · C.R. Bard, Inc. · Oct 1996
4F NYLEX ANGIOGRAPHIC CATHETER
K962759 · Cordis Corp. · Oct 1996
1-4F INFINITI ANGIOGRAPHIC CATHETER
K960975 · Cordis Corp. · Apr 1996