Cleared Traditional

K880551 - MODEL 439-07 AND 439-09 LIFELINE MYOCAR...

K880551 is an FDA 510(k) clearance for MODEL 439-07 AND 439-09 LIFELINE MYOCAR..., manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K880551 · Intermedics, Inc. · Cardiovascular device
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Mar 1988
Decision
27d
Days
Class 3
Risk

K880551 is an FDA 510(k) clearance for the MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on March 7, 1988 after a review of 27 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K880551

510(k) Number K880551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date March 07, 1988
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K880551.
MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT
K881712 · Medtronic Vascular · May 1988
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
NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
K875199 · Biotronik Sales, Inc. · Feb 1988
PERMANENT MYOCARDIAL LEADS MP SERIES
K872971 · Oscor Medical Corp. · Feb 1988
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
K873962 · Medtronic Vascular · Feb 1988