FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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)
K Number: K211061
·
Decision Jun 10, 2021
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
70
Applicant Total
6
Review Days
62
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Basic Information
- Device Name
- 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)
- K Number
- K211061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thrombolex, Inc.
- Date Received
- April 9, 2021
- Decision Date
- June 10, 2021
- Product Code
- QEY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QEY), ordered by most recent decision date.
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Versus Catheter (VS110-8B)
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BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter
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BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
FDA 510(k)
FDA Class 2
·Cardiovascular
EKOS+ Endovascular Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Thrombolex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter | Jul 3, 2023 | Substantially Equivalent |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | Apr 20, 2023 | Substantially Equivalent |
| K193071 | Bashir Plus Endovascular Catheter | Dec 17, 2019 | Substantially Equivalent |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | Oct 18, 2019 | Substantially Equivalent |
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 | Feb 25, 2019 | Substantially Equivalent |