Cleared Traditional

K921311 - CORDIS SHUTTLE CATHETER W/ SIDEHOLES

K921311 is an FDA 510(k) clearance for CORDIS SHUTTLE CATHETER W/ SIDEHOLES, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K921311 · Cordis Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 1992
Decision
175d
Days
Class 2
Risk

K921311 is an FDA 510(k) clearance for the CORDIS SHUTTLE CATHETER W/ SIDEHOLES. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on September 9, 1992 after a review of 175 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 Cordis Corp. devices

FDA 510(k) Submission Details - K921311

510(k) Number K921311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1992
Decision Date September 09, 1992
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
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 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K921311.
TRIGUIDE-PLUS GUIDING CATHETER
K923245 · Scimed Life Systems, Inc. · Feb 1993
GUIDING CATHETER
K923518 · Interventional Therapeutics Corp. · Jan 1993
SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER
K922611 · Scimed Life Systems, Inc. · Jan 1993
E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION
K914984 · E-Z-Em, Inc. · May 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · Cook, Inc. · May 1992
RIGHT ATRIAL CATHETER KITS
K920331 · Akcess Medical Products, Inc. · Apr 1992