Cleared Traditional

K820487 - IMPLANTIBLE SUTURE SLEEVE

K820487 is an FDA 510(k) clearance for IMPLANTIBLE SUTURE SLEEVE, 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 52-day FDA review.

K820487 · Intermedics, Inc. · Cardiovascular device
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Apr 1982
Decision
52d
Days
Class 3
Risk

K820487 is an FDA 510(k) clearance for the IMPLANTIBLE SUTURE SLEEVE. 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 April 16, 1982 after a review of 52 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 - K820487

510(k) Number K820487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1982
Decision Date April 16, 1982
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
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 K820487.
MEDTRONIC #6993
K820989 · Medtronic Vascular · Aug 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889 · Cordis Corp. · Aug 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947 · Pacesetter Systems · Aug 1982
BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60
K820767 · Siemens Elema AB · Apr 1982
LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.
K820121 · Telectronics, Inc. · Feb 1982
INTERSEPT CARDIOTOMY RESERVOIR/FILTER
K813205 · Extracorporeal Medical Specialities, Inc. · Jan 1982