Cleared Traditional

K891121 - MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM

K891121 is an FDA 510(k) clearance for MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K891121 · Boston Scientific Corp · Cardiovascular device
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Dec 1989
Decision
278d
Days
Class 2
Risk

K891121 is an FDA 510(k) clearance for the MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on December 5, 1989 after a review of 278 days - an extended review 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: 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 - K891121

510(k) Number K891121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date December 05, 1989
Days to Decision 278 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
153d slower than avg
Panel avg: 125d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K891121.
USCI(R) ACCESS(TM) INTRODUCER SET
K901452 · C.R. Bard, Inc. · May 1990
HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS
K897041 · C.R. Bard, Inc. · Mar 1990
DUAL GUIDE INTRODUCER CATHETER
K895044 · Cook, Inc. · Feb 1990
HEMOSTASIS VALVE
K895214 · Applied Vascular Devices, Inc. · Nov 1989
OBTURATOR
K894157 · Argon Medical Corp. · Sep 1989
DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
K894343 · Daig Corp. · Sep 1989