Cleared Traditional

K790764 - PACEMAKERS WITHOUT SILASTIC COATING

K790764 is an FDA 510(k) clearance for PACEMAKERS WITHOUT SILASTIC COATING, manufactured by Telectronics, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K790764 · Telectronics, Inc. · Cardiovascular device
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Apr 1979
Decision
7d
Days
Class 3
Risk

K790764 is an FDA 510(k) clearance for the PACEMAKERS WITHOUT SILASTIC COATING. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1979 after a review of 7 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 Telectronics, Inc. devices

FDA 510(k) Submission Details - K790764

510(k) Number K790764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1979
Decision Date April 26, 1979
Days to Decision 7 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
118d faster than avg
Panel avg: 125d · This submission: 7d
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K790764.
GENERATOR, 16 SERIES, MODIFIED TOP CAP
K790868 · Telectronics, Inc. · May 1979
OMNI-STANICOR-(THETA) MODEL 217
K790690 · Cordis Corp. · May 1979
PULSE GENERATOR MODEL 61 AND 128
K790562 · Ela Medical, Inc. · May 1979
MICROLITH MODELS 505
K790432 · Cardiac Pacemakers, Inc. · Mar 1979
MINILITH AND MICROLITH
K790276 · Cardiac Pacemakers, Inc. · Feb 1979
PULSE GENERATOR, IMPLANTABLE CARDIAC
K782149 · Telectronics, Inc. · Feb 1979