Numed PTS X Sizing Balloon Catheter
FDA 510(k) K041306 · NuMED, Inc.
510(k) numberK041306
Submission
- Device name
- Numed PTS X Sizing Balloon Catheter
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- May 17, 2004
- Decision date
- June 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K213915 | BIB Stent Placement CatheterNVM · Special | 01/12/2022SE |
| K211910 | Z-6 Atrioseptostomy CatheterDXF · Special | 07/19/2021SE |
| K211134 | BIB Stent Placement CatheterNVM · Special | 05/27/2021SE |
| K190974 | D'Vill IntroducerDYB · Special | 05/14/2019SE |
| K171206 | D'Vill IntroducerDYB · Traditional | 10/20/2017SE |
| K161451 | BIB Stent Placement CatheterNVM · Traditional | 09/22/2016SE |
| K160598 | REBOA Balloon CatheterMJN · Traditional | 06/20/2016SE |
| K160889 | BIB Stent Placement CatheterNVM · Traditional | 05/20/2016SE |
| K131869 | Pts-X Sizing Balloon CatheterMJN · Special | 08/08/2013SE |
| K122012 | Z-Med Z-Med IIOZT · Traditional | 10/04/2012SE |
Questions and answers
When was Numed PTS X Sizing Balloon Catheter cleared by the FDA?
Numed PTS X Sizing Balloon Catheter (K041306) received a 510(k) decision of Substantially Equivalent on June 10, 2004, 24 days after the submission was received.
What is the product code of K041306?
The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.