Cleared Traditional

INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

K955122 · Intermedics, Inc. · Cardiovascular
Nov 1996
Decision
361d
Days
Class 3
Risk

About This 510(k) Submission

K955122 is an FDA 510(k) clearance for the INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on November 4, 1996, 361 days after receiving the submission on November 9, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K955122 FDA.gov
FDA Decision Cleared ST
Date Received November 09, 1995
Decision Date November 04, 1996
Days to Decision 361 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTB — Permanent Pacemaker Electrode
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3680

Similar Devices — DTB Permanent Pacemaker Electrode

All 486
BIOTRONIK ENDOCARDIAL PACING LEADS
K061212 · Biotronik, Inc. · Jul 2006
PERMANENT PACING LEAD, MODEL PY2
K041809 · Oscor, Inc. · Aug 2004
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
K040569 · Oscor, Inc. · Apr 2004
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · Medtronic Vascular · May 2003
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
K031210 · Metronic, Inc. · May 2003
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
K023205 · Biotronik, Inc. · Apr 2003