Cleared Traditional

ISOLATION SLEEVE, MODEL 349-01 (K790098) - FDA 510(k) Clearance

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

K790098 · Intermedics, Inc. · Cardiovascular device
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Jan 1979
Decision
8d
Days
Class 3
Risk

K790098 is an FDA 510(k) clearance for the ISOLATION SLEEVE, MODEL 349-01. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1979 after a review of 8 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 K790098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1979
Decision Date January 24, 1979
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
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 K790098.
PACEMAKERS WITHOUT SILASTIC COATING
K790764 · Telectronics, Inc. · Apr 1979
PULSE GENERATOR, IMPLANTABLE CARDIAC
K782149 · Telectronics, Inc. · Feb 1979
BIPOLAR, STANICOR LAMBDA MODEL 236,235
K790014 · Cordis Corp. · Feb 1979
ISOLATION SLEEVE, MODEL 347-01
K790099 · Intermedics, Inc. · Jan 1979
ISOLATION SLEEVE, MODEL 348-01
K790100 · Intermedics, Inc. · Jan 1979
ISOLATION SLEEVE, MODEL 346-01
K790101 · Intermedics, Inc. · Jan 1979