Cleared Traditional

K811106 - INTERMEDICS POLY FLEX ENDOCARDIAL PACING

K811106 is an FDA 510(k) clearance for INTERMEDICS POLY FLEX ENDOCARDIAL PACING, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K811106 · Intermedics, Inc. · Cardiovascular device
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May 1981
Decision
34d
Days
Class 3
Risk

K811106 is an FDA 510(k) clearance for the INTERMEDICS POLY FLEX ENDOCARDIAL PACING. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 34 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K811106

510(k) Number K811106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1981
Decision Date May 27, 1981
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K811106.
MODEL B BIPOLAR ENDOCARDIAL LEAD
K811878 · Cook Pacemaker Corp. · Aug 1981
MODEL A UNIPOLAR ENDOCARDIAL LEAD
K811879 · Cook Pacemaker Corp. · Aug 1981
CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL
K811539 · Cordis Corp. · Jul 1981
TYPE YC ENDOCARDIAL LEAD
K810491 · Biotronik Sales, Inc. · Mar 1981
TYPE YR ENDOCARDIAL LEAD
K810492 · Biotronik Sales, Inc. · Mar 1981
TYPE N ENDOCARDIAL LEAD
K810493 · Biotronik Sales, Inc. · Mar 1981