Cleared Traditional

K843880 - LOW PROFILE STEERABLE BALLOON DILATION

K843880 is the FDA 510(k) clearance for LOW PROFILE STEERABLE BALLOON DILATION by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K843880 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Nov 1984
Decision
56d
Days
Class 2
Risk

K843880 is an FDA 510(k) clearance for the LOW PROFILE STEERABLE BALLOON DILATION. 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 November 27, 1984 after a review of 56 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K843880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1984
Decision Date November 27, 1984
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 K843880.
ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
K844972 · Advanced Cardiovascular Systems, Inc. · May 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
MEDI-TECH DILATATION CATHETERS
K843383 · Medi-Tech, Inc. · Oct 1984
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY
K841961 · Scimed Life Systems, Inc. · Oct 1984
BALLOON DILATION CATHETER
K843501 · Advanced Cardiovascular Systems, Inc. · Oct 1984