Cleared Traditional

K897106 - MEDI-TECH DILATATION CATHETERS ULTRA THIN II

K897106 is an FDA 510(k) clearance for MEDI-TECH DILATATION CATHETERS ULTRA TH..., manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K897106 · Boston Scientific Corp · Cardiovascular device
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Oct 1990
Decision
299d
Days
Class 2
Risk

K897106 is an FDA 510(k) clearance for the MEDI-TECH DILATATION CATHETERS ULTRA THIN II. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on October 16, 1990 after a review of 299 days - an extended review 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: 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K897106

510(k) Number K897106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1989
Decision Date October 16, 1990
Days to Decision 299 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
174d slower than avg
Panel avg: 125d · This submission: 299d
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 345
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K897106.
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.
K902317 · Mallinckrodt Medical · Dec 1990
OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER
K902367 · Vas-Cath, Inc. · Dec 1990
PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
K900094 · Boston Scientific Corp · Oct 1990
GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER
K903606 · North American Instrument Corp. · Sep 1990
SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER
K902091 · Schneider Intl., Ltd. · Sep 1990
SMALL VESSEL BALLOON DILATATION CATHETER
K897124 · Boston Scientific Corp · Jul 1990