Cleared Traditional

K914141 - CORDIS DUAL LUMEN PRESSURE MONITORING C...

K914141 is an FDA 510(k) clearance for CORDIS DUAL LUMEN PRESSURE MONITORING C..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K914141 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
37d
Days
Class 2
Risk

K914141 is an FDA 510(k) clearance for the CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 37 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 Cordis Corp. devices

FDA 510(k) Submission Details - K914141

510(k) Number K914141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date October 23, 1991
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

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 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K914141.
SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS
K914312 · Scimed Life Systems, Inc. · Nov 1991
MERIT CUSTOM KIT
K913682 · Merit Medical Systems, Inc. · Nov 1991
ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION
K912477 · Interventional Therapeutics Corp. · Nov 1991
CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
K914007 · Cordis Corp. · Oct 1991
ACS RX SUPPORT CATHETER
K911957 · Advanced Cardiovascular Systems, Inc. · Sep 1991
SCIMED 7 FR. & 8 FR.
K913364 · Scimed Life Systems, Inc. · Aug 1991