Atlas FDA

MODEL 6984M LEAD EXTENDER KIT

FDA 510(k) clearance K915724 · decided 1992-02-18

Clearance details

K-number
K915724
Device name
MODEL 6984M LEAD EXTENDER KIT
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1991-12-20
Decision date
1992-02-18
Days to decision
60 days
Clearance type
Traditional
Product code
DTD
Device class
2
Regulation number
870.3620
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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

RecordFirmDate
IS4/DF4 Port Plug (K143463)Oscor, Inc.2015-03-19
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP (K132008)Medtronic, Inc.2013-07-30
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (K041574)Guidant Corporation2004-07-12
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV (K031164)Oscor, Inc.2003-06-19
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR (K024156)Oscor, Inc.2003-01-14
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (K010787)Oscor, Inc.2001-05-22
A1-CS-SB Y-ADAPTER, MODEL 124 871 (K003454)Biotronik, Inc.2001-01-18
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT (K000210)Medtronic Vascular2000-02-23
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT (K982220)Medtronic Vascular1998-10-15
BK-N SEALING CAP (K971930)Biotronik, Inc.1997-08-14
A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE (K970388)Biotronik, Inc.1997-08-14
BK-A; BK-B; BK-IS SEALING CAP (K970204)Biotronik, Inc.1997-04-29

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