Cleared Traditional

K864943 - NUMED BALLOON WEDGE PRESSURE CATHETER

K864943 is the FDA 510(k) clearance for NUMED BALLOON WEDGE PRESSURE CATHETER by NuMED, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K864943 · NuMED, Inc. · Cardiovascular device
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Feb 1987
Decision
65d
Days
Class 2
Risk

K864943 is an FDA 510(k) clearance for the NUMED BALLOON WEDGE PRESSURE CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on February 20, 1987 after a review of 65 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 NuMED, Inc. devices

Submission Details

510(k) Number K864943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1986
Decision Date February 20, 1987
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 291
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K864943.
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438 · C.R. Bard, Inc. · Nov 1987
GUIDING CATHETER
K873004 · Mallinckrodt Critical Care · Sep 1987
DOUBLE LUMEN CATHETER
K872248 · Cordis Corp. · Aug 1987
NUMED BALLOON ANGIOGRAPHIC CATHETERS
K864940 · NuMED, Inc. · Feb 1987
CORDIS CONTRAST INJECTION LINES
K864141 · Cordis Corp. · Nov 1986
TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER
K863137 · Terumo Medical Corp. · Oct 1986