Cleared Traditional

K892530 - CATHETERS FOR BALLOON OCCLUSION FEMORAL...

K892530 is an FDA 510(k) clearance for CATHETERS FOR BALLOON OCCLUSION FEMORAL..., manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K892530 · Arrow Intl., Inc. · Cardiovascular device
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Sep 1989
Decision
168d
Days
Class 2
Risk

K892530 is an FDA 510(k) clearance for the CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 168 days - an extended review 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: 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K892530

510(k) Number K892530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date September 26, 1989
Days to Decision 168 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
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

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 56
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K892530.
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
BARD CATH LAB THERMODILUTION CATHETER
K893474 · C.R. Bard, Inc. · Sep 1989
MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER
K883948 · NuMED, Inc. · Apr 1989
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465 · Abbott Laboratories · May 1988