Cleared Traditional

K891121 - MEDI-TECH AMPLATZ INTRODUCER SHEALTH SY...

K891121 is the FDA 510(k) clearance for MEDI-TECH AMPLATZ INTRODUCER SHEALTH SY... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 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
DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
K894343 · Daig Corp. · Sep 1989
MODIFIED LABELING TO PERMANENT LEAD INTRODUCER
K894431 · Daig Corp. · Sep 1989
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
K885179 · Baxter Healthcare Corp · Aug 1989