Not Cleared Traditional

A1-A,ABP,B,MBP, LEAD CONNECTORS (K970388) - FDA 510(k) Clearance

Also marketed or referenced as:
PEH ADAPTER SLEEVE

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970388 · Biotronik, Inc. · Cardiovascular device
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Aug 1997
Decision
192d
Days
Class 2
Risk

K970388 is an FDA 510(k) submission (not cleared) for the A1-A,ABP,B,MBP, LEAD CONNECTORS. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Not Cleared (DENG) decision on August 14, 1997 after a review of 192 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K970388 FDA.gov
FDA Decision Not Cleared PT (PT)
Date Received February 03, 1997
Decision Date August 14, 1997
Days to Decision 192 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 125d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 102
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K970388.
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210 · Medtronic Vascular · Feb 2000
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
K982220 · Medtronic Vascular · Oct 1998
MODEL 6984M LEAD EXTENDER KIT
K915724 · Medtronic Vascular · Feb 1992
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
K911302 · Medtronic Vascular · Jul 1991
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
K910630 · Medtronic Vascular · Apr 1991
MODEL 5857-3M LEAD END CAP KIT
K911048 · Medtronic Vascular · Apr 1991