Cleared Traditional

K893763 - MODELS 1113 AND 1114 PACEMAKER LEADS

K893763 is the FDA 510(k) clearance for MODELS 1113 AND 1114 PACEMAKER LEADS by Possis Medical, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K893763 · Possis Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1989
Decision
56d
Days
Class 3
Risk

K893763 is an FDA 510(k) clearance for the MODELS 1113 AND 1114 PACEMAKER LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Possis Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 56 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 Possis Medical, Inc. devices

Submission Details

510(k) Number K893763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1989
Decision Date July 14, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
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 274
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K893763.
MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
K896313 · Medtronic Vascular · Mar 1990
PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
K895136 · Medtronic Vascular · Feb 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447 · Pacesetter Systems · Dec 1989
IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
K894040 · Medtronic Vascular · Jul 1989
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
K891905 · Pacesetter Systems · Jun 1989
MEDTRONIC MODEL 5866-45 SIZING SLEEVE
K890644 · Medtronic Vascular · May 1989