Atlas FDA

ADAPTING SLEEVE

FDA 510(k) clearance K813154 · decided 1981-12-02

Clearance details

K-number
K813154
Device name
ADAPTING SLEEVE
Applicant
Pacesetter Systems
Decision
Substantially Equivalent
Date received
1981-11-06
Decision date
1981-12-02
Days to decision
26 days
Clearance type
Traditional
Product code
DTD
Device class
2
Regulation number
870.3620
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, 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
CARBON TIP CARDIAC PACING LEAD (P800041/S015)Pacesetter Systems1996-01-04
CARBON TIP CARDIAC PACING LEAD (P800041/S014)Pacesetter Systems1994-10-17
CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S011)Pacesetter Systems1994-05-25
CARBON TIPPED LEAD ALT.PROD.TRAYS (P800041/S012)Pacesetter Systems1992-11-18
CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S010)Pacesetter Systems1990-12-18
CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S009)Pacesetter Systems1990-12-10
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S008)Pacesetter Systems1989-06-19
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S007)Pacesetter Systems1987-06-22