Cleared Traditional

K884005 - ENDOCARDIAL PACING LEADS-ANCHORING SLEE...

K884005 is the FDA 510(k) clearance for ENDOCARDIAL PACING LEADS-ANCHORING SLEE... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K884005 · Medtronic Vascular · Cardiovascular device
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Dec 1988
Decision
75d
Days
Class 3
Risk

K884005 is an FDA 510(k) clearance for the ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED. 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 December 5, 1988 after a review of 75 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 Medtronic Vascular devices

Submission Details

510(k) Number K884005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1988
Decision Date December 05, 1988
Days to Decision 75 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
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 364
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K884005.
MEDTRONIC MODEL 4058 PACING LEAD
K883743 · Medtronic Vascular · Jan 1989
IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436
K884278 · Telectronics, Inc. · Dec 1988
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
K884394 · Ela Medical, Inc. · Dec 1988
MEDTRONIC MODEL 4951P
K881810 · Medtronic Vascular · Oct 1988
MODEL 5866-34A PACEMAKER LEAD ADAPTOR
K883203 · Medtronic Vascular · Sep 1988
BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD
K883602 · Intermedics, Inc. · Sep 1988