Cleared Traditional

NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR (K875199) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K875199 · Biotronik Sales, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
62d
Days
Class 3
Risk

K875199 is an FDA 510(k) clearance for the NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik Sales, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotronik Sales, Inc. devices

Submission Details

510(k) Number K875199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1987
Decision Date February 18, 1988
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K875199.
MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875100 · Intermedics, Inc. · May 1988
MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K872126 · Intermedics, Inc. · Mar 1988
MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD
K880551 · Intermedics, Inc. · Mar 1988
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
K873962 · Medtronic Vascular · Feb 1988
MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD
K874792 · Medtronic Vascular · Jan 1988
POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD
K874531 · Intermedics, Inc. · Jan 1988