FDA.reportPublic FDA data

THROMBOLEX, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30154891453015489145THROMBOLEX, INC.1N2026-01-0175 Britain Dr. New Britain PA US 18901

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850005115021Bashir™ S-B Endovascular Catheter 7Fr, 10.0cm basket - 71012678983986amy@thrombolex.com
00850005115038Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion - 72102678983986amy@thrombolex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2282061240473213K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterQEY2023-07-03
2282061610489667K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101QEY2023-04-20
2282061473104370K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)QEY2021-06-10
2282061471208500K193071Bashir Plus Endovascular CatheterQEY2019-12-17
2282061352311807K192598Bashir S-B Endovascular Catheter, Ref. No. 7101QEY2019-10-18
2282061486505876K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200QEY2019-02-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QEY92023-07-03

PMN#

GUDID#