Atlas FDA

ANGIO-SEAL VASCULAR CLOSURE DEVICE

FDA premarket approval P930038/S052 · decided 2008-09-26

Approval details

PMA number
P930038
Supplement
S052
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
ANGIO-SEAL VASCULAR CLOSURE DEVICE
Generic name
Device, hemostasis, vascular
Applicant
Terumo Medical Corporation
Date received
2007-12-28
Decision date
2008-09-26
Days to decision
273 days
Decision code
APPR
Product code
MGB
Advisory committee
Cardiovascular
Expedited review
No
Location
Elkton, MD
Statement
APPROVAL FOR USE OF THE ANGIO-SEAL VASCULAR CLOSURE DEVICE IN CLOSURE OF FEMORAL VENOUS PUNCTURE SITES AND FOR THE REMOVAL OF THE PRECAUTION STATEMENT RELATING TO THE USE OF THE ANTICOAGULANT WARFARIN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL AND FEMORAL VENOUS PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR PERCUTANEOUS TR

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

510(k) clearances by this applicant

RecordFirmDate
R2P Navicross (K231044)Terumo Medical Corporation2023-07-27
TR BAND Radial Compression Device (K213531)Terumo Medical Corporation2021-12-20
R2P Destination Slender Guiding Sheath (K193125)Terumo Medical Corporation2020-01-06
Glidesheath Slender Tibial Pedal Kit (K181237)Terumo Medical Corporation2018-08-03
Glidesheath Slender (K173831)Terumo Medical Corporation2018-05-08
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath (K172995)Terumo Medical Corporation2017-11-21
R2P Destination Slender Guiding Sheath (K171491)Terumo Medical Corporation2017-10-05
Glidesheath (K152173)Terumo Medical Corporation2015-12-01