Dardik Carotid Shunt
FDA 510(k) K001621 · Vascutech, Inc.
510(k) numberK001621
Submission
- Device name
- Dardik Carotid Shunt
- Applicant
- Vascutech, Inc.
Burlington, MA, US - Received
- May 26, 2000
- Decision date
- December 6, 2000
- 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
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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 |
|---|---|---|
| K992942 | Lemaitre Occlusion CatheterMJN · Traditional | 04/13/2000SE |
| K992933 | Lemaitre Irrigation CatheterDXE · Traditional | 03/08/2000SE |
| K992934 | Lemaitre Venous Thrombectomy CatheterDXE · Traditional | 03/01/2000SE |
| K992940 | Lemaitre Balloon Catheter with IrrigationDXE · Traditional | 02/22/2000SE |
| K992941 | Lemaitre Biliary CatheterLQR · Traditional | 01/12/2000SE |
| K992368 | Lemaitre Embolectomy CatheterDXE · Traditional | 12/09/1999SE |
| K980723 | 2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT)MGZ · Traditional | 02/12/1999SE |
| K946352 | Lemaitre Valvulotome IIMGZ · Traditional | 06/21/1995SE |
| K932009 | The Samuels Retrograd ValvulotomeMGZ · Traditional | 09/21/1993SE |
| K932184 | Sterile Lemaitre Glow 'N Tell TapeKFX · Traditional | 07/22/1993SE |
Questions and answers
When was Dardik Carotid Shunt cleared by the FDA?
Dardik Carotid Shunt (K001621) received a 510(k) decision of Substantially Equivalent on December 6, 2000, 194 days after the submission was received.
What is the product code of K001621?
The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.