Cleared Traditional

K953265 - SCIMED ANGIOGRAPHIC KITS

K953265 is an FDA 510(k) clearance for SCIMED ANGIOGRAPHIC KITS, manufactured by Scimed Life Systems, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K953265

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.

DQY Device Classification - Class 2, Special Controls

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 783
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K953265.
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K962362 · Cordis Corp. · Aug 1996
SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
K961280 · Scimed Life Systems, Inc. · May 1996
MEDTRONIC SHERPA GUIDING CATHETER
K955651 · Medtronics Interventional Vascular · Jan 1996
ACS TOURGIDE GUIDING CATHETER
K953987 · Advanced Cardiovascular Systems, Inc. · Dec 1995
MEDTRONIC GC IV CORONARY GUIDING CATHETER
K950490 · Medtronics Interventional Vascular · Nov 1995
5F ENVOY GUIDING CATHETER (MODIFICATION)
K954251 · Cordis Neurovascular, Inc. · Oct 1995