Atlas FDA

PACING SYSTEM ANALYZER

FDA 510(k) clearance K803313 · decided 1981-02-23

Clearance details

K-number
K803313
Device name
PACING SYSTEM ANALYZER
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1980-12-31
Decision date
1981-02-23
Days to decision
54 days
Clearance type
Traditional
Product code
DTE
Device class
2
Regulation number
870.3600
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
Solo Pace Control (K241781)Solo Pace, Inc.2025-01-10
Lifetech Cardio Temporary Pacemaker (K232721)Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2024-01-07
Medtronic Model 5392 External Pulse Generator (EPG) (K201011)Medtronic, Inc.2020-05-13
Medtronic Model 5392 External Pulse Generator (EPG) (K190825)Medtronic, Inc.2019-04-30
Lifetech Cardio Model 8301 Temporary Pacemaker (K182839)Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2019-02-28
Medtronic Model 5392 External Pulse Generator (EPG) (K181973)Medtronic, Inc.2018-08-21
Medtronic Model 53401 External Pulse Generator (EPG) (K180873)Medtronic, Inc.2018-04-19
Medtronic Temporary External Pacemaker 53401 (K162054)Medtronic, Inc.2016-10-18
Medtronic Model 5392 External Pulse Generator (EPG) (K162550)Medtronic, Inc.2016-10-12
Medtronic Model 5392 External Pulse Generator (EPG) (K150246)Medtronic, Inc.2015-02-18
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (K132924)Medtronic, Inc.2013-10-31
PSA SERIES (K123916)Osypka Medical, Inc.2013-04-09

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