Cleared Traditional

K951720 - SCIMED EXPO ANGIOGRAPHIC CATHETER

K951720 is the FDA 510(k) clearance for SCIMED EXPO ANGIOGRAPHIC CATHETER by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K951720 · Scimed Life Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1995
Decision
69d
Days
Class 2
Risk

K951720 is an FDA 510(k) clearance for the SCIMED EXPO ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K951720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1995
Decision Date June 22, 1995
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
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 291
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K951720.
EVOLUTION MICROCATHETER
K953114 · Boston Scientific Corp · Sep 1995
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER
K950882 · B.Braun Medical, Inc. · Aug 1995
TRANSIT-2 INFUSION CATHETER
K950910 · Cordis Neurovascular, Inc. · Aug 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