Cleared Traditional

K771770 - XYREL-RA MODELS 5994/5995

K771770 is the FDA 510(k) clearance for XYREL-RA MODELS 5994/5995 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K771770 · Medtronic Vascular · Cardiovascular device
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Jan 1978
Decision
107d
Days
Class 3
Risk

K771770 is an FDA 510(k) clearance for the XYREL-RA MODELS 5994/5995. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on January 4, 1978 after a review of 107 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 Medtronic Vascular devices

Submission Details

510(k) Number K771770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1977
Decision Date January 04, 1978
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
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 338
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K771770.
CARDIAC PACER, MODEL 208
K780066 · Cordis Corp. · Jan 1978
PULSE GENERATORS, MODELS 5972/5973
K780061 · Medtronic Vascular · Jan 1978
PULSE GENERATORS
K772357 · Medtronic Vascular · Jan 1978
CARDIAC PULSE GENERATORS 5982/5983
K771786 · Medtronic Vascular · Jan 1978
PULSE GENERATOR, A-V SEQ.
K772202 · Medtronic Vascular · Dec 1977
CARDIAC PULSE GENERATOR, MODEL 150L
K772026 · Telectronics, Inc. · Nov 1977