Cleared Traditional

K871861 - IMPLANTABLE PROGRAMMABLE CARDIAC PULSE ...

K871861 is an FDA 510(k) clearance for IMPLANTABLE PROGRAMMABLE CARDIAC PULSE ..., 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 23-day FDA review.

K871861 · Telectronics, Inc. · Cardiovascular device
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Jun 1987
Decision
23d
Days
Class 3
Risk

K871861 is an FDA 510(k) clearance for the IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 23 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 - K871861

510(k) Number K871861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1987
Decision Date June 05, 1987
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
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 K871861.
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
K873528 · Intermedics, Inc. · Oct 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871992 · Telectronics, Inc. · Aug 1987
MEDTRONIC CLASSIX MODELS 8436/8437/8438
K871866 · Medtronic Vascular · Aug 1987
ASTRA T2, T4 AND T6
K865013 · Cardiac Pacemakers, Inc. · Feb 1987
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
K863898 · Ela Medical, Inc. · Feb 1987
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
K862226 · Pacesetter Systems · Feb 1987