Cleared Traditional

K844687 - MEDTRONIC MODEL 6912

K844687 is the FDA 510(k) clearance for MEDTRONIC MODEL 6912 by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K844687 · Medtronic Vascular · Cardiovascular device

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Feb 1985

Decision

60d

Days

Class 2

Risk

K844687 is an FDA 510(k) clearance for the MEDTRONIC MODEL 6912. 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 February 1, 1985 after a review of 60 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	K844687 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 03, 1984
Decision Date	February 01, 1985
Days to Decision	60 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

65d faster than avg

Panel avg: 125d · This submission: 60d

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 84

Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K844687.

PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD

K844857 · Pacesetter Systems · Feb 1985

BIOTRONIK DNP UNIPOLAR

K841450 · Biotronik Sales, Inc. · Feb 1985

BIOTRONIK DY-UNIPOLAR

K841451 · Biotronik Sales, Inc. · Feb 1985

EPICARDIAL, UNIPOLAR LEAD 4951

K842065 · Medtronic Vascular · Jan 1985

TRANSVENOUS TINED VENTRICULAR LEAD

K842145 · Medtronic Vascular · Jan 1985

PERMATHANE 865 & 867 UNIPOLAR POLYURETH

K843703 · Pacesetter Systems · Jan 1985

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 K844687

Medtronic Vascular

Minneapolis, MN · US

EDWARD W NUMAINVILL

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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