Cleared Traditional

K830608 - USCI GRUNTZIG DILACA BALLOON DILATION

K830608 is the FDA 510(k) clearance for USCI GRUNTZIG DILACA BALLOON DILATION by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K830608 · C.R. Bard, Inc. · Cardiovascular device
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Mar 1983
Decision
27d
Days
Class 2
Risk

K830608 is an FDA 510(k) clearance for the USCI GRUNTZIG DILACA BALLOON DILATION. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K830608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1983
Decision Date March 24, 1983
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 239
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K830608.
FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE
K831659 · American Edwards Laboratories · Aug 1983
LOW PROFILE STEERABLE BALLOON DILATA
K831403 · Advanced Cardiovascular Systems, Inc. · Jun 1983
FORGARTY CHIN PERIPHERAL INTRAOPERATIVE
K830733 · American Edwards Laboratories · Apr 1983
INDEFLATOR
K822245 · Advanced Cardiovascular Systems, Inc. · Aug 1982
CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH.
K812168 · Cordis Corp. · Aug 1981
FOGARTY BALLON ANGIOPLASTY CATHETERS
K803057 · American Edwards Laboratories · Jan 1981