Atlas FDA

INLINE AUTOTRANSFUSION SYSTEM

FDA 510(k) clearance K890171 · decided 1989-06-15

Clearance details

K-number
K890171
Device name
INLINE AUTOTRANSFUSION SYSTEM
Applicant
Conmedcorp
Decision
Substantially Equivalent
Date received
1989-01-17
Decision date
1989-06-15
Days to decision
149 days
Clearance type
Traditional
Product code
CAC
Device class
2
Regulation number
868.5830
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Utica, NY, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Conmedcorp

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
XTRA Collection sets; XTRA Sequestration set X (K241236)Sorin Group Italia S.R.L.2024-08-16
Aventus Clot Management System (K240426)Inquis Medical2024-05-14
XTRA Autotransfusion System (with XTRA Bowl sets) (K240584)Sorin Group Italia S.R.L.2024-04-29
FlowSaver Blood Return System (80-101) (K231782)Inari Medical, Inc.2023-07-14
FlowSaver Blood Return System (K221483)Inari Medical, Inc.2023-02-17
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (K221722)Haemonetics Corporation2022-11-15
Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain (K201305)Atrium Medical Corporation2021-09-03
Hemafuse System (K210862)Sisu Global Health2021-07-29
FlowSaver Blood Filter (K210176)Inari Medical2021-07-22
CATSmart, Automated Blood Processing Autotransfusion System (K210089)Fresenius Kabi AG2021-02-11
ProCell Surgical Sponge-Blood Recovery Unit (K193361)Procell Surgical, Inc.2020-06-01
CATSmart (K192368)Fresenius Kabi AG2019-09-27

Recalls involving this device

No recalls on record reference this clearance.