Cleared Traditional

K881810 - MEDTRONIC MODEL 4951P

K881810 is an FDA 510(k) clearance for MEDTRONIC MODEL 4951P, manufactured by Medtronic Vascular. 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.

K881810 · Medtronic Vascular · Cardiovascular device
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Oct 1988
Decision
168d
Days
Class 3
Risk

K881810 is an FDA 510(k) clearance for the MEDTRONIC MODEL 4951P. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 13, 1988 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K881810

510(k) Number K881810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1988
Decision Date October 13, 1988
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 423
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K881810.
PERMANENT PACING LEADS PYBJ SERIES
K882345 · Oscor Medical Corp. · Oct 1988
PERMANENT PACING LEAD MODEL RXBJ SERIES
K882462 · Oscor Medical Corp. · Oct 1988
POLYSAFE(TM) IMPLANTABLE PACING LEAD
K884024 · Cardiac Control Systems, Inc. · Oct 1988
POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP
K883015 · Cardiac Control Systems, Inc. · Oct 1988
POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP
K883016 · Cardiac Control Systems, Inc. · Sep 1988
MODEL 5866-34A PACEMAKER LEAD ADAPTOR
K883203 · Medtronic Vascular · Sep 1988