Cleared Traditional

MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT (K910630) - FDA 510(k) Clearance

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

K910630 · Medtronic Vascular · Cardiovascular device

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Apr 1991

Decision

64d

Days

Class 2

Risk

K910630 is an FDA 510(k) clearance for the MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT. 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 April 18, 1991 after a review of 64 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

Submission Details

510(k) Number	K910630 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 13, 1991
Decision Date	April 18, 1991
Days to Decision	64 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

61d faster than avg

Panel avg: 125d · This submission: 64d

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 36

Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K910630.

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 5857-3M LEAD END CAP KIT

K911048 · Medtronic Vascular · Apr 1991

MODEL 5866-37M LEAD ADAPTOR KIT

K904575 · Medtronic Vascular · Feb 1991

MODEL 5866-34 LEAD ADAPTOR KIT

K900627 · Medtronic Vascular · Apr 1990

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K910630

Medtronic Vascular

Minneapolis, MN · US

JENNIFER M MARRONE

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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