Cleared Traditional

K910608 - PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP

K910608 is an FDA 510(k) clearance for PERMANENT IMPLANTABLE FH ENDOCARDIAL LE..., 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 168-day FDA review.

K910608 · Biotronik, GmbH & Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
168d
Days
Class 3
Risk

K910608 is an FDA 510(k) clearance for the PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP. 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 July 30, 1991 after a review of 168 days - an extended review 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 - K910608

510(k) Number K910608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date July 30, 1991
Days to Decision 168 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
43d slower than avg
Panel avg: 125d · This submission: 168d
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 K910608.
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
K910924 · Pacesetter Systems · Aug 1991
100 CM PERMANENT PACING LEAD MODELS
K911273 · Telectronics Pacing Systems, Inc. · Aug 1991
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS
K910528 · Possis Medical, Inc. · Aug 1991
OSCOR MEDICAL CORP. PERMANENT PACING PAD
K905182 · Oscor Medical Corp. · May 1991
PERMANENT PACING LEAD
K905300 · Oscor Medical Corp. · May 1991
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
K903948 · Intermedics, Inc. · Apr 1991