Atlas FDA

PLEUR-EVAC CARDIOTOMY RESERVOIR

FDA 510(k) clearance K925046 · decided 1993-04-20

Clearance details

K-number
K925046
Device name
PLEUR-EVAC CARDIOTOMY RESERVOIR
Applicant
Deknatel, Inc.
Decision
Substantially Equivalent
Date received
1992-10-06
Decision date
1993-04-20
Days to decision
196 days
Clearance type
Traditional
Product code
DTN
Device class
2
Regulation number
870.4400
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
San Jose-Heredia, CR
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Deknatel

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
Inspire HCR and HCR DUAL cardiotomy reservoirs (K251783)Sorin Group Italia S.R.L.2025-12-22
Quantum Perfusion Hybrid System (K241206)Spectrum Medical S.R.L.2024-07-18
MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL (K241053)Medtronic Cardiac Surgery2024-05-15
BMR 1900 PHISIO (K223361)Sorin Group Italia S.R.L.2023-06-10
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (K170583)Medtronic, Inc.2017-03-17
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (K161733)Sorin Group Italia S.R.L.2017-03-08
Capiox Advance Hardshell Reservoir (K153143)Terumo Cardiovascular Systems Corporation2015-12-02
Intersept Filtered Cardiotomy Reservoir (K151110)Medtronic, Inc.2015-05-27
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH (K141432)Maquet Cardiopulmonary, AG2014-07-07
AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE (K141233)Medtronic, Inc.2014-06-12
INITARY BETTER BLADDER-PEDIATRIC (K140321)Circulatory Technology, Inc.2014-04-17
VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT (K132166)Maquet Cardiopulmonary, AG2013-10-30

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S006)Deknatel, Inc.1989-06-16
NONABSORBABLE SURG. SUTURES, NYLON (N85060/S007)Deknatel, Inc.1989-06-16
DEKLENE(TM) (P810028/S011)Deknatel, Inc.1989-06-16
DEKLENE(TM) (P810028/S010)Deknatel, Inc.1989-02-02
NONABSORBABLE SURG. SUTURES, NYLON (N85060/S005)Deknatel, Inc.1989-01-31
DEKLENE(TM) (P810028/S008)Deknatel, Inc.1989-01-31
CHROMIC GUT SUTURE (N84381/S007)Deknatel, Inc.1989-01-31
NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S004)Deknatel, Inc.1989-01-31