Cleared Traditional

K844972 - ADV CARDIO SYS DBL LUMEN BALLOON DILATA...

K844972 is the FDA 510(k) clearance for ADV CARDIO SYS DBL LUMEN BALLOON DILATA... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K844972 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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May 1985
Decision
143d
Days
Class 2
Risk

K844972 is an FDA 510(k) clearance for the ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 16, 1985 after a review of 143 days - within the typical 510(k) review window.

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: 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K844972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1984
Decision Date May 16, 1985
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
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 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K844972.
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO
K853746 · Advanced Cardiovascular Systems, Inc. · Oct 1985
CORDIS PTA CATHETER-PERCUTANEOUS CATHETER
K844913 · Cordis Corp. · Aug 1985
ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO
K851854 · Advanced Cardiovascular Systems, Inc. · Aug 1985
SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT
K850075 · Scimed Life Systems, Inc. · Apr 1985
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER
K850760 · Scimed Life Systems, Inc. · Apr 1985
LOW PROFILE STEERABLE BALLOON DILATION
K843880 · Advanced Cardiovascular Systems, Inc. · Nov 1984