Cleared Traditional

K863418 - MODEL 352-01 SILICONE RUBBER ISOLATION ...

K863418 is an FDA 510(k) clearance for MODEL 352-01 SILICONE RUBBER ISOLATION ..., manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K863418 · Intermedics, Inc. · Cardiovascular device
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Sep 1986
Decision
21d
Days
Class 3
Risk

K863418 is an FDA 510(k) clearance for the MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on September 24, 1986 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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 - K863418

510(k) Number K863418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date September 24, 1986
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.

DXY Device Classification - Class 3, Premarket Approval

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
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 - DXY Implantable Pacemaker Pulse-generator

All 354
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K863418.
NEOS-M VS-1 PULSE GENERATOR
K863879 · Biotronik Sales, Inc. · Dec 1986
CORDIS MULTICOR II MODEL 402D PACER
K863417 · Cordis Corp. · Oct 1986
MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)
K863582 · Cook Pacemaker Corp. · Oct 1986
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
K862974 · Medtronic Vascular · Sep 1986
NEOS VS-1, PULSE GENERATOR
K860921 · Biotronik Sales, Inc. · Aug 1986
MIKROS, MIKROS VS-1, PULSE GENERATOR
K860922 · Biotronik Sales, Inc. · Aug 1986