Occlusion Balloon Catheter
FDA 510(k) K960832 · Interventional Therapeutics Corp.
510(k) numberK960832
Submission
- Device name
- Occlusion Balloon Catheter
- Applicant
- Interventional Therapeutics Corp.
Fremont, CA, US - Received
- February 29, 1996
- Decision date
- May 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MJN – Catheter, Intravascular Occluding, Temporary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
Other 510(k)s with product code MJN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243795 | pREBOA-PRO CatheterMJN · Traditional | Prytime Medical Devices, Inc. | 09/05/2025SE |
| K251358 | Bridge Plus Occlusion Balloon (590-002)MJN · Traditional | Philips Image Guided Therapy Devices | 06/24/2025SE |
| K221294 | preCARDIA Occlusion SystemMJN · Traditional | Abiomed, Inc. | 06/30/2023SESU |
| K214060 | LANDMARK REBOA CatheterMJN · Traditional | Zien Medical Technologies, Inc. | 09/19/2022SE |
| K211610 | Fogarty Occlusion CatheterMJN · Traditional | Edwards Lifesciences, LLC | 02/14/2022SE |
| K212324 | RenovoCathMJN · Special | Renovorx, Inc. | 08/23/2021SE |
| K210602 | AortaSTAT Occlusion DeviceMJN · Traditional | Renalpro Medical, Inc. | 07/09/2021SE |
| K210358 | Neurescue deviceMJN · Traditional | Neurescue Aps | 05/21/2021SE |
| K201652 | COBRA-OS KitMJN · Traditional | Front Line Medical Technologies, Inc. | 02/22/2021SESK |
| K203540 | Bridge Occlusion BalloonMJN · Special | Spectranetics, Inc. | 12/23/2020SE |
More from Spectranetics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950398 | Catheter, Balloon TypeDQO · Traditional | 10/05/1995SE |
| K945588 | Disposable 1CC Syringe with Luer LockFMF · Traditional | 02/10/1995SE |
| K944354 | Contour EmboliHCG · Traditional | 12/13/1994SE |
| K930456 | Intherm Single-Stick Radially Expanding DilatorKNT · Traditional | 11/17/1993SE |
| K914866 | Itc Contour Emboli, ModificationHCG · Traditional | 11/09/1993SE |
| K931025 | Intherm Stasis Valve SystemFGE · Traditional | 09/28/1993SE |
| K931278 | Intherm Single-Stick Radially Expanding DilatorGCJ · Traditional | 07/23/1993SE |
| K922609 | Itc Catheters W/ HydromerDQY · Traditional | 04/30/1993SE |
| K925876 | Itc Bunji Platinum Embolization CoilHCG · Traditional | 04/15/1993SE |
| K925523 | Itc Bunji Platinum Embolization CoilHCG · Traditional | 03/23/1993SE |
Questions and answers
When was Occlusion Balloon Catheter cleared by the FDA?
Occlusion Balloon Catheter (K960832) received a 510(k) decision of Substantially Equivalent on May 29, 1996, 90 days after the submission was received.
What is the product code of K960832?
The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.