BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101— 510(k) K222095
Substantially EquivalentThrombolex, Inc.
FDA 510(k) clearance K222095 for BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101, Substantially Equivalent on 2023-04-20. Applicant: Thrombolex, Inc.. Device class: 2.
Clearance details
- Applicant
- Thrombolex, Inc.
- Product code
- Code QEY
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Britain, PA, US
Recent devices under product code QEY
view allMore clearances from Thrombolex, Inc.
view all- K211061 — BASHIR 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)
- K193071 — Bashir Plus Endovascular Catheter
- K192598 — Bashir S-B Endovascular Catheter, Ref. No. 7101
- K183290 — Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
Data sourced from openFDA. This site is unofficial and independent of the FDA.