Cleared Traditional

MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE (K863418) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

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

Submission Details

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.

Device Classification

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 181
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K863418.
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871861 · Telectronics, Inc. · Jun 1987
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
K862459 · Medtronic Vascular · Jan 1987
CORDIS MULTICOR II MODEL 402D PACER
K863417 · Cordis Corp. · Oct 1986
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
K862974 · Medtronic Vascular · Sep 1986
MODIFIED MODELS 8320/8322/8329/8316/8317/8318
K861719 · Medtronic Vascular · Jul 1986
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
K862037 · Medtronic Vascular · Jun 1986