Atlas FDA

PULSE GENERATOR, A-V SEQ.

FDA 510(k) clearance K772202 · decided 1977-12-20

Clearance details

K-number
K772202
Device name
PULSE GENERATOR, A-V SEQ.
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1977-11-30
Decision date
1977-12-20
Days to decision
20 days
Clearance type
Traditional
Product code
DXY
Device class
3
Regulation number
870.3610
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (K993434)Biotronik, Inc.1999-11-10
OPUS S MODEL 4121 AND 4124 PACEMAKERS (K970072)Ela Medical, Inc.1997-08-29
PIKOS LP 01, PIKOS LP E01 (K945627)Biotronik, Inc.1996-03-04
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (K953866)Medtronic Vascular1995-12-15
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (K954092)Medtronic Vascular1995-12-15
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (K953417)Cook Pacemaker Corp.1995-09-29
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (K952328)Biotronik, Inc.1995-09-29
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (K952364)Ela Medical, Inc.1995-09-01
PELLETHANE 75D (K940039)Medtronic Vascular1995-07-12
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES (K950751)Medtronic Vascular1995-05-15
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (K946188)Cardiac Control Systems, Inc.1995-05-15
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER (K950210)Cardiac Control Systems, Inc.1995-05-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089)Medtronic Vascular2025-12-19
Endurant II/IIs Stent Graft System (P100021/S131)Medtronic Vascular2025-10-23
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129)Medtronic Vascular2025-09-15
Resolute Onyx (P160043/S088)Medtronic Vascular2025-06-26
Endurant Stent Graft System (P100021/S130)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072)Medtronic Vascular2025-05-20
Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069)Medtronic Vascular2025-05-08