Cleared Traditional

K833427 - IMPLANTABLE BIPOLAR CARDIAC PULSE GEN

K833427 is an FDA 510(k) clearance for IMPLANTABLE BIPOLAR CARDIAC PULSE GEN, 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 129-day FDA review.

K833427 · Telectronics, Inc. · Cardiovascular device
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Feb 1984
Decision
129d
Days
Class 3
Risk

K833427 is an FDA 510(k) clearance for the IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. 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 February 10, 1984 after a review of 129 days - within the typical 510(k) review window.

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 - K833427

510(k) Number K833427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1983
Decision Date February 10, 1984
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
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 K833427.
CARDIAC PULSE GENERATOR 254-18
K841074 · Intermedics, Inc. · May 1984
CARCIAC PULSE GENERATOR 254-20
K841075 · Intermedics, Inc. · May 1984
PACEMAKER 147 VVI-THE OPTINIA
K840701 · Telectronics, Inc. · May 1984
IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN
K833428 · Telectronics, Inc. · Feb 1984
IMPLANTABLE PULSE GENERATOR
K834096 · Intermedics, Inc. · Dec 1983
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
K833798 · Telectronics, Inc. · Dec 1983