Atlas FDA

MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING

FDA 510(k) clearance K891013 · decided 1989-08-02

Clearance details

K-number
K891013
Device name
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1989-02-28
Decision date
1989-08-02
Days to decision
155 days
Clearance type
Traditional
Product code
CCC
Device class
2
Regulation number
868.1150
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Minneapolis, MN, 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
ISCALERT SENSOR SYSTEM (K071165)Alertis Medical AS2007-11-07
TRENDCARE CALIBRATOR MODEL SCU 7007 (K983198)Diametrics Medical, Ltd.1999-11-23
PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM (K972314)Diametrics Medical, Ltd.1997-12-19
PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (K953893)Biomedical Sensors, Inc.1997-11-04
POINT-OF-CARE BLOOD GAS MONITOR SYSTEM (K961790)Optical Sensors, Inc.1997-04-09
OLYMPUS CRITICAL CARE MONITORING SYSTEM (K963935)Optical Sensors, Inc.1997-01-23
POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM (K951094)Optical Sensors, Inc.1996-01-16
PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (K940188)Biomedical Sensors, Ltd.1995-11-13
SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE (K931185)Optical Sensors, Inc.1993-10-21
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (K901548)Shiley, Inc.1991-01-14
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY (K870911)American Bentley1987-05-29
OXYGEN ANALYZER 110 (K780185)Siemens Corp.1978-03-17

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S (P160043/S094)Medtronic Vascular2026-06-05
RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043/S093)Medtronic Vascular2026-05-29
Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S (P160043/S092)Medtronic Vascular2026-05-13
Endurant™ II/IIs Stent Graft System (P100021/S132)Medtronic Vascular2026-05-12
Onyx Frontier Zotarolimus Eluting Coronary Stent System (P160043/S090)Medtronic Vascular2026-03-25
Endurant™, Endurant™ II/lls Stent Graft System (P100021/S134)Medtronic Vascular2026-02-27
Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System (P100040/S074)Medtronic Vascular2026-02-27
Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System (P100021/S133)Medtronic Vascular2026-01-27