Cleared Traditional

K812990 - INTERMEDICS POLYFLEX-MODEL 483-03 LEAD

K812990 is an FDA 510(k) clearance for INTERMEDICS POLYFLEX-MODEL 483-03 LEAD, 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 21-day FDA review.

K812990 · Intermedics, Inc. · Cardiovascular device
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Nov 1981
Decision
21d
Days
Class 3
Risk

K812990 is an FDA 510(k) clearance for the INTERMEDICS POLYFLEX-MODEL 483-03 LEAD. 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 November 16, 1981 after a review of 21 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 - K812990

510(k) Number K812990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1981
Decision Date November 16, 1981
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
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 K812990.
ELECTRODE, PACEMAKER, PERMANENT
K810139 · Pacesetter Systems · Nov 1981
PACEPATH IMPLANT. ENDOCARD. PACING LEAD
K810286 · Pacesetter Systems · Nov 1981
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD
K812989 · Intermedics, Inc. · Nov 1981
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD
K812991 · Intermedics, Inc. · Nov 1981
MODEL 833 ENDOCARDIAL TINED LEAD
K812815 · Pacesetter Systems · Oct 1981
MODEL 841 ENDOCARDIAL TINED LEAD
K812816 · Pacesetter Systems · Oct 1981