Cleared Traditional

K952828 - MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM

K952828 is the FDA 510(k) clearance for MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K952828 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
59d
Days
Class 2
Risk

K952828 is an FDA 510(k) clearance for the MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on August 18, 1995 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Boston Scientific Corp devices

Submission Details

510(k) Number K952828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1995
Decision Date August 18, 1995
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 390
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K952828.
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CORDIS INTRODUCING CATHETER
K945524 · Cordis Corp. · Apr 1995
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K945616 · Cordis Corp. · Mar 1995
FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET
K945396 · B.Braun Medical, Inc. · Mar 1995