Cleared Traditional

K963092 - MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER

K963092 is an FDA 510(k) clearance for MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CA..., manufactured by Adam Spencer Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K963092 · Adam Spencer Corp. · Cardiovascular device
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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

FDA 510(k) Submission Details - K963092

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
Combination Product No
PCCP Authorized No
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.

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 403
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K963092.
3F ANGIOPTIC ANGIOGRAPHIC CATHETER
K964033 · AngioDynamics, Inc. · May 1997
SPYGLASS ANGIOGRAPHIC CATHETER
K965249 · Daig Corp. · Feb 1997
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K964859 · Scimed Life Systems, Inc. · Feb 1997
ASC HIGH PRESSURE BRAIDED TUBES
K964331 · Adam Spencer Corp. · Jan 1997
USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC
K960056 · C.R. Bard, Inc. · Oct 1996
LAGUNA SOFTIP DIAGNOSTIC CATHETERS
K961499 · Boston Scientific Scimed, Inc. · Oct 1996