Cleared Traditional

K791782 - USCI BALLOON DILATATION INFLATION DEV.

K791782 is an FDA 510(k) clearance for USCI BALLOON DILATATION INFLATION DEV., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K791782 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1979
Decision
90d
Days
Class 2
Risk

K791782 is an FDA 510(k) clearance for the USCI BALLOON DILATATION INFLATION DEV.. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1979 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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.

FDA 510(k) Submission Details - K791782

510(k) Number K791782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1979
Decision Date December 11, 1979
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 210
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K791782.
MALLINCKRODT DIAG. MEDIA WARMER
K821401 · Forma Scientific, Inc. · Jun 1982
QUICK FILL
K800823 · Medrad, Inc. · Apr 1980
ANGIOPLASTY INJECTOR
K800613 · Medrad, Inc. · Apr 1980
USCI PRESSURE GAUGE
K791793 · C.R. Bard, Inc. · Dec 1979
DYNAJECT
K790835 · Atomic Products Corp. · Jun 1979
DISPOSABLE SYRINGE FILL TUBE
K781334 · Mallinckrodt Group, Inc. · Aug 1978
K791782 · USCI BALLOON DILATATION INFLATION DEV.
Download PDF C.R. Bard, Inc.