Cleared Traditional

CORDIS SHUTTLE CATHETER (K915777) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915777 · Cordis Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 1992
Decision
49d
Days
Class 2
Risk

K915777 is an FDA 510(k) clearance for the CORDIS SHUTTLE CATHETER. 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 February 11, 1992 after a review of 49 days - a notably fast clearance 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: 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 Cordis Corp. devices

Submission Details

510(k) Number K915777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date February 11, 1992
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 344
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K915777.
CORDIS SHUTTLE CATHETER W/ SIDEHOLES
K921311 · Cordis Corp. · Sep 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · Cook, Inc. · May 1992
CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER
K915374 · Cordis Corp. · Feb 1992
SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS
K913830 · Scimed Life Systems, Inc. · Nov 1991
CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER
K912777 · Cordis Corp. · Sep 1991
TURBO SUPPORT CATHETER
K910116 · Datascope Corp. · Jun 1991