Cleared Traditional

K851848 - PERCUTANEOUS TRANSLUMINAL BLOOD DILATIO...

K851848 is the FDA 510(k) clearance for PERCUTANEOUS TRANSLUMINAL BLOOD DILATIO... by Mansfield Scientific, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K851848 · Mansfield Scientific, Inc. · Cardiovascular device
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Jul 1985
Decision
84d
Days
Class 2
Risk

K851848 is an FDA 510(k) clearance for the PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Mansfield Scientific, Inc. (Mansfield, US). The FDA issued a Cleared decision on July 19, 1985 after a review of 84 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 Mansfield Scientific, Inc. devices

Submission Details

510(k) Number K851848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date July 19, 1985
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
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 244
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K851848.
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
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