Cleared Traditional

K894976 - ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.

K894976 is an FDA 510(k) clearance for ALTERNATE PACKAGING CONF. OF PACEMAKER ..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K894976 · Medtronic Vascular · Cardiovascular device
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Oct 1989
Decision
66d
Days
Class 2
Risk

K894976 is an FDA 510(k) clearance for the ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 12, 1989 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K894976

510(k) Number K894976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1989
Decision Date October 12, 1989
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
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 - DTD Pacemaker Lead Adaptor

All 96
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K894976.
IMPLANTABLE ADAPTOR 033-380
K890895 · Telectronics, Inc. · Mar 1990
3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
K900605 · Possis Medical, Inc. · Mar 1990
TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING
K895971 · Telectronics Pacing Systems, Inc. · Feb 1990
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
K894718 · Intermedics, Inc. · Sep 1989
DAIG PACEMAKER LEAD ADAPTOR
K870562 · Daig Corp. · Mar 1987
PACEMAKER LEAD ADAPTER
K862656 · Cordis Corp. · Jul 1986