Cleared Traditional

PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN (K802553) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K802553 · Daig Corp. · Cardiovascular device
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Jan 1981
Decision
93d
Days
Class 3
Risk

K802553 is an FDA 510(k) clearance for the PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Daig Corp. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1981 after a review of 93 days - within the typical 510(k) review window.

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 Daig Corp. devices

Submission Details

510(k) Number K802553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1980
Decision Date January 16, 1981
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
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 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K802553.
CORDIS PERVENOUS ATRIAL LEAD
K810432 · Cordis Corp. · Mar 1981
POLY FLEX IMPLANTABLE PACING LEAD
K802295 · Intermedics, Inc. · Feb 1981
CORDIS MULTIFILAR PERVENOUS VENTRIC. LD
K810202 · Cordis Corp. · Feb 1981
INTERMEDICS' LIFELINE TLE ENDOCARDIAL
K801172 · Intermedics, Inc. · Dec 1980
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)
K801284 · Medtronic Vascular · Dec 1980
MEDTRONIC MODEL 6958
K800870 · Medtronic Vascular · Nov 1980