Cleared Traditional

K953265 - SCIMED ANGIOGRAPHIC KITS

K953265 is the FDA 510(k) clearance for SCIMED ANGIOGRAPHIC KITS by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K953265 · Scimed Life Systems, Inc. · Cardiovascular device
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Jan 1996
Decision
187d
Days
Class 2
Risk

K953265 is an FDA 510(k) clearance for the SCIMED ANGIOGRAPHIC KITS. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on January 16, 1996 after a review of 187 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K953265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1995
Decision Date January 16, 1996
Days to Decision 187 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
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 581
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K953265.
VISTA BRITE TIP CATHETERS
K962830 · Cordis Corp. · Oct 1996
CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS
K962362 · Cordis Corp. · Aug 1996
SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
K961280 · Scimed Life Systems, Inc. · May 1996
ACS TOURGIDE GUIDING CATHETER
K953987 · Advanced Cardiovascular Systems, Inc. · Dec 1995
5F ENVOY GUIDING CATHETER (MODIFICATION)
K954251 · Cordis Neurovascular, Inc. · Oct 1995
FASGUIDE
K951159 · Target Therapeutics · Sep 1995