Cleared Traditional

K911840 - INTERFLO MEDICAL MODEL PA3-H CCO/PAC CA...

K911840 is the FDA 510(k) clearance for INTERFLO MEDICAL MODEL PA3-H CCO/PAC CA... by Intec Medical, Inc.. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K911840 · Intec Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
39d
Days
Class 2
Risk

K911840 is an FDA 510(k) clearance for the INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Intec Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on June 3, 1991 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Intec Medical, Inc. devices

Submission Details

510(k) Number K911840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1991
Decision Date June 03, 1991
Days to Decision 39 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 41
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K911840.
SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]
K951566 · Baxter Healthcare Corp · Nov 1995
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742 · Baxter Healthcare Corp · Jan 1994
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
K924452 · Baxter Healthcare Corp · Oct 1993
STEALTH DILATION CATHETER SYSTEM/MODIFICATION
K904287 · Target Therapeutics · Jan 1991
SOFT-WEDGE(TM) SYRINGE
K900879 · Baxter Healthcare Corp · May 1990
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
K896466 · Baxter Healthcare Corp · Feb 1990