Cleared Traditional

K875064 - SCIMED INFLATION DEVICE, MODEL SM 2000

K875064 is an FDA 510(k) clearance for SCIMED INFLATION DEVICE, manufactured by Scimed Life Systems, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K875064 · Scimed Life Systems, Inc. · Cardiovascular device
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Feb 1988
Decision
82d
Days
Class 2
Risk

K875064 is an FDA 510(k) clearance for the SCIMED INFLATION DEVICE, MODEL SM 2000. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 29, 1988 after a review of 82 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.

FDA 510(k) Submission Details - K875064

510(k) Number K875064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date February 29, 1988
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

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 404
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K875064.
PERIPHERAL DILATATION CATHETER
K880298 · Medi-Tech, Inc. · Apr 1988
KENSEY CATHETER
K880194 · Theratek, Inc. · Apr 1988
ANGIOPLASTY BALLOON INFLATION DEVICE
K880158 · L.O.N. Research, Inc. · Mar 1988
MODIFIED SIMPSON PERIPHERAL ATHEROCATH
K874706 · Devices For Vascular Intervention, Inc. · Jan 1988
NUMED PTA CATHETERS
K871796 · NuMED, Inc. · Dec 1987
SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER
K872542 · Angiomedics, Inc. · Sep 1987
K875064 · SCIMED INFLATION DEVICE, MODEL SM 2000
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