Cleared Traditional

K883948 - MODIFIED NUMED BALLOON ANGIOGRAPHIC CAT...

K883948 is the FDA 510(k) clearance for MODIFIED NUMED BALLOON ANGIOGRAPHIC CAT... by NuMED, Inc.. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K883948 · NuMED, Inc. · Cardiovascular device
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Apr 1989
Decision
220d
Days
Class 2
Risk

K883948 is an FDA 510(k) clearance for the MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on April 21, 1989 after a review of 220 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 NuMED, Inc. devices

Submission Details

510(k) Number K883948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date April 21, 1989
Days to Decision 220 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
95d slower than avg
Panel avg: 125d · This submission: 220d
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 53
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K883948.
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
K896466 · Baxter Healthcare Corp · Feb 1990
CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
K892530 · Arrow Intl., Inc. · Sep 1989
BARD CATH LAB THERMODILUTION CATHETER
K893474 · C.R. Bard, Inc. · Sep 1989
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465 · Abbott Laboratories · May 1988
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
K874117 · Medtronic Vascular · Nov 1987
DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR
K862119 · Parke-Davis Co. · Aug 1986