Atlas FDA

FOGARTY VESSEL CALIBRATOR

FDA 510(k) clearance K902143 · decided 1990-10-16

Clearance details

K-number
K902143
Device name
FOGARTY VESSEL CALIBRATOR
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1990-05-15
Decision date
1990-10-16
Days to decision
154 days
Clearance type
Traditional
Product code
DWP
Device class
2
Regulation number
870.4475
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Santa Ana, CA, 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
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (K220981)Fehling Surgical Instruments, Inc.2023-04-20
Geomed Vascular Dilators (K183438)Geomed Medizin-Technik GmbH & Co.2019-09-03
Vessel Dilator (K163524)Fetzer Medical GmbH & Co. KG2017-06-29
VASCULAR PROBE, VASCULAR PROBE ES (K130896)Synovis Life Technologies, Inc.2013-04-24
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (K100518)Instrumed International, Inc.2010-08-31
KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (K030788)Geister Medizin Technik GmbH2003-07-12
RDI CARDIAC INSULATION PAD (K960312)R D Intl.1996-04-19
LEMAITRE-BOOKWALTER VESSEL DEVICES (K912548)Vascutech, Inc.1991-09-18
LAPAROSCOPIC VESSEL ARTICULATOR (K911475)United States Endoscopy Group, Inc.1991-07-02
ROBICSEK PROBE/RETRACTOR (K910682)Bio-Vascular, Inc.1991-05-08
FLO-RESTER(R) VESSEL SIZER (K905159)Bio-Vascular, Inc.1991-02-07
PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) (K891786)Pioneering Technologies, Inc.1989-10-12

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02