Cleared Traditional

K800793 - IMPLANTABLE PROGRAM. CARDIAC PACEMAKER

K800793 is an FDA 510(k) clearance for IMPLANTABLE PROGRAM. CARDIAC PACEMAKER, 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 162-day FDA review.

K800793 · Telectronics, Inc. · Cardiovascular device
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Sep 1980
Decision
162d
Days
Class 3
Risk

K800793 is an FDA 510(k) clearance for the IMPLANTABLE PROGRAM. CARDIAC PACEMAKER. 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 September 18, 1980 after a review of 162 days - an extended review 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 - K800793

510(k) Number K800793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1980
Decision Date September 18, 1980
Days to Decision 162 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
37d slower than avg
Panel avg: 125d · This submission: 162d
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 K800793.
SORIN PULSE GENERATOR, MODEL #LIT-214
K801640 · Bentley Laboratories, Inc. · Oct 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
K801978 · Pacesetter Systems · Sep 1980
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN
K802028 · Telectronics, Inc. · Sep 1980
SIEMENS-ELEMA PULSE GENERATOR 625
K801508 · Siemens Elema AB · Sep 1980
MEDTRONIC MODEL 2409
K800226 · Medtronic Vascular · Sep 1980
INSULATING SHEATH
K801910 · Cordis Corp. · Sep 1980