LDOB OCCLUSION BALLOON CATHETER
FDA 510(k) clearance K002286 · decided 2001-03-22
Clearance details
- K-number
- K002286
- Device name
- LDOB OCCLUSION BALLOON CATHETER
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-27
- Decision date
- 2001-03-22
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- MJN
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bloomington, IN, 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.
| Record | Firm | Date |
|---|---|---|
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| Fogarty Occlusion Catheter (K211610) | Edwards Lifesciences, LLC | 2022-02-14 |
| RenovoCath (K212324) | Renovorx, Inc. | 2021-08-23 |
| AortaSTAT Occlusion Device (K210602) | Renalpro Medical, Inc. | 2021-07-09 |
| Neurescue device (K210358) | Neurescue Aps | 2021-05-21 |
| COBRA-OS Kit (K201652) | Front Line Medical Technologies, Inc. | 2021-02-22 |
| Bridge Occlusion Balloon (K203540) | Spectranetics, Inc. | 2020-12-23 |
| pREBOA-PRO Catheter (K200459) | Prytime Medical Devices, Inc. | 2020-06-03 |
| Gatekeeper Balloon Catheter (K192786) | Arch Catheter, LLC | 2020-04-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zenith® Iliac Branch (P020018/S064) | Cook, Inc. | 2025-05-30 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065) | Cook, Inc. | 2025-04-09 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S063) | Cook, Inc. | 2024-04-29 |
| Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061) | Cook, Inc. | 2023-12-14 |
| Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062) | Cook, Inc. | 2023-12-13 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S060) | Cook, Inc. | 2022-01-20 |
| Zenith AAA Endovascular Graft (P020018/S059) | Cook, Inc. | 2020-10-08 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055) | Cook, Inc. | 2018-10-10 |