Cleared Traditional

SENTRA (K843060) - FDA 510(k) Clearance

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

K843060 · Cardiac Pacemakers, Inc. · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Sep 1984

Decision

48d

Days

Class 2

Risk

K843060 is an FDA 510(k) clearance for the SENTRA. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1984 after a review of 48 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number	K843060 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 03, 1984
Decision Date	September 20, 1984
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

77d faster than avg

Panel avg: 125d · This submission: 48d

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 K843060.

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

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 K843060

Cardiac Pacemakers, Inc.

Walker, MI · US

Regulatory profile

76 submissions 76 cleared

100% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,218

Regulatory data since 1976

FDA monthly sync Active