Cleared Traditional

K830734 - FORGARTY BALLOON CALIBRATOR

K830734 is the FDA 510(k) clearance for FORGARTY BALLOON CALIBRATOR by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K830734 · American Edwards Laboratories · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1983
Decision
35d
Days
Class 2
Risk

K830734 is an FDA 510(k) clearance for the FORGARTY BALLOON CALIBRATOR. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 35 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 American Edwards Laboratories devices

Submission Details

510(k) Number K830734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date April 12, 1983
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
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 K830734.
ANGIOGRAPHIC NEEDLE
K831189 · Medrad, Inc. · May 1983
CENTRAL VEIN CATHERIZATION KIT-14-690-
K830788 · Norton Performance Plastics Corp. · Apr 1983
DIAGNOSTIC INTRAVASCULAR CATHETER
K830415 · Mallinckrodt Critical Care · Apr 1983
VARIOUS CARDIOVASCULAR PRODUCTS
K823357 · C.R. Bard, Inc. · Mar 1983
INTRACATH-DA INTRAVENOUS CATH. PLACEMENT
K823064 · Parke-Davis Co. · Jan 1983
SIDEARM Y-ADAPTOR
K823243 · American Edwards Laboratories · Jan 1983