Cleared Traditional

K910528 - BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS

K910528 is an FDA 510(k) clearance for BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS, manufactured by Possis Medical, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K910528 · Possis Medical, Inc. · Cardiovascular device
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Aug 1991
Decision
182d
Days
Class 3
Risk

K910528 is an FDA 510(k) clearance for the BIPOLAR SUTURELESS MYOCARDIAL PACING 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 August 9, 1991 after a review of 182 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 Possis Medical, Inc. devices

FDA 510(k) Submission Details - K910528

510(k) Number K910528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1991
Decision Date August 09, 1991
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
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 421
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K910528.
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP
K910609 · Biotronik, GmbH & Co. · Aug 1991
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
K910924 · Pacesetter Systems · Aug 1991
100 CM PERMANENT PACING LEAD MODELS
K911273 · Telectronics Pacing Systems, Inc. · Aug 1991
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
K910608 · Biotronik, GmbH & Co. · Jul 1991
OSCOR MEDICAL CORP. PERMANENT PACING PAD
K905182 · Oscor Medical Corp. · May 1991
PERMANENT PACING LEAD
K905300 · Oscor Medical Corp. · May 1991