Cleared Traditional

K897106 - MEDI-TECH DILATATION CATHETERS ULTRA TH...

K897106 is the FDA 510(k) clearance for MEDI-TECH DILATATION CATHETERS ULTRA TH... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 238
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K897106.
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K905773 · Mallinckrodt Medical · Jan 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.
K902317 · Mallinckrodt Medical · Dec 1990
PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
K900094 · Boston Scientific Corp · Oct 1990
SMALL VESSEL BALLOON DILATATION CATHETER
K897124 · Boston Scientific Corp · Jul 1990
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
K901018 · Boston Scientific Corp · May 1990
LE PTA CATHETER
K894250 · Baxter Healthcare Corp · Mar 1990