Cleared Traditional

K950910 - TRANSIT-2 INFUSION CATHETER

K950910 is the FDA 510(k) clearance for TRANSIT-2 INFUSION CATHETER by Cordis Neurovascular, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K950910 · Cordis Neurovascular, Inc. · Cardiovascular device
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Aug 1995
Decision
176d
Days
Class 2
Risk

K950910 is an FDA 510(k) clearance for the TRANSIT-2 INFUSION CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on August 8, 1995 after a review of 176 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 Cordis Neurovascular, Inc. devices

Submission Details

510(k) Number K950910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date August 08, 1995
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
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 277
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K950910.
ANGIOPTIC ANGIOGRAPHIC CATHETER
K954423 · AngioDynamics, Inc. · Dec 1995
EVOLUTION MICROCATHETER
K953114 · Boston Scientific Corp · Sep 1995
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER
K950882 · B.Braun Medical, 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