Cleared Traditional

K891576 - FEM-FLEX FEMORAL ACCESS CANNULATION SET

K891576 is an FDA 510(k) clearance for FEM-FLEX FEMORAL ACCESS CANNULATION SET, manufactured by Research Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K891576 · Research Medical, Inc. · Cardiovascular device
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Oct 1989
Decision
206d
Days
Class 2
Risk

K891576 is an FDA 510(k) clearance for the FEM-FLEX FEMORAL ACCESS CANNULATION SET. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 12, 1989 after a review of 206 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Research Medical, Inc. devices

FDA 510(k) Submission Details - K891576

510(k) Number K891576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date October 12, 1989
Days to Decision 206 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 125d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 270
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K891576.
RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE
K896778 · Research Medical, Inc. · Feb 1990
RMI ANTEPLEGIA CANNULA
K896636 · Research Medical, Inc. · Feb 1990
KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN
K895352 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1989
MODIFIED STOCKERT-SHILEY VENOUS CATHETER
K890980 · Shiley, Inc. · May 1989
SARNS VENT CATHETER
K890024 · 3M Company · Mar 1989
MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY
K885188 · Quinton, Inc. · Feb 1989