Cleared Traditional

K901709 - DNP 60-B UNIPOLAR ENDOCARDIAL LEAD

K901709 is an FDA 510(k) clearance for DNP 60-B UNIPOLAR ENDOCARDIAL LEAD, manufactured by Biotronik, GmbH & Co.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K901709 · Biotronik, GmbH & Co. · Cardiovascular device
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May 1990
Decision
39d
Days
Class 3
Risk

K901709 is an FDA 510(k) clearance for the DNP 60-B UNIPOLAR ENDOCARDIAL LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik, GmbH & Co. (Lake Oswego, US). The FDA issued a Cleared decision on May 22, 1990 after a review of 39 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, GmbH & Co. devices

FDA 510(k) Submission Details - K901709

510(k) Number K901709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1990
Decision Date May 22, 1990
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 420
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K901709.
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742 · Ela Medical, Inc. · Jul 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147 · Pacesetter Systems · Jul 1990
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458
K901402 · Telectronics Pacing Systems, Inc. · Jun 1990
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984 · Medtronic Vascular · May 1990
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
K900550 · Pacesetter Systems · Apr 1990
MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
K896313 · Medtronic Vascular · Mar 1990