Atlas FDA

SATURATION/HEMATOCRIT MONITOR SYSTEM

FDA 510(k) clearance K910421 · decided 1991-10-15

Clearance details

K-number
K910421
Device name
SATURATION/HEMATOCRIT MONITOR SYSTEM
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1991-01-30
Decision date
1991-10-15
Days to decision
258 days
Clearance type
Traditional
Product code
DRY
Device class
2
Regulation number
870.4330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Anaheim, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 (K133157)Medtronic, Inc.2014-10-23
CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K133658)Terumo Cardiovascular Systems Corp.2014-07-25
CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K123039)Terumo Cardiovascular Systems Corp.2012-11-20
M4 MONITOR (K110957)Spectrum Medical, Llp2011-05-31
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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