24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524
FDA 510(k) K012143 · Medtronic Cardiac Surgical Products
510(k) numberK012143
Submission
- Device name
- 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524
- Applicant
- Medtronic Cardiac Surgical Products
Grand Rapids, MI, US - Received
- July 10, 2001
- Decision date
- October 24, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRA – Catheter, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1280
- Specialty
- Cardiovascular
Other 510(k)s with product code DRA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | Boston Scientific Corporation | 07/24/2026SE |
| K250529 | Globe Introducer (601-01001)DRA · Traditional | Kardium, Inc. | 06/03/2025SE |
| K233248 | FARADRIVE Steerable SheathDRA · Traditional | Boston Scientific Corporation | 12/11/2023SE |
| K232321 | FlexCath Contour Steerable SheathDRA · Traditional | Medtronic, Inc. | 10/31/2023SE |
| K223824 | POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping…DRA · Traditional | Boston Scientific Corporation | 03/22/2023SE |
| K221397 | MitraClip G4 Steerable Guide CatheterDRA · Special | Abbott Medical | 09/28/2022SE |
| K221044 | AcQGuide® VUE Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/05/2022SE |
| K211100 | AcQGuide MAX Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/14/2021SE |
| K202620 | FlexCath Advance Steerable Sheath and DilatorDRA · Traditional | Medtronic Cryocath, LP | 11/13/2020SE |
| K192422 | Steerable Introducer 12FDRA · Traditional | Freudenberg Medical, LLC | 10/04/2019SE |
More from Freudenberg Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K022272 | Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)DWF · Traditional | 01/08/2003SE |
| K013013 | Medtronic DLP Arterial Cannula with 3D Tip - 22 Fr.DWF · Traditional | 12/04/2001SE |
| K010737 | Select Cap Arterial Cannula with Pressure Monitoring Line, Model…DWF · Special | 04/04/2001SE |
| K000776 | Medtronic DLP Arterial Cannulae with 3D TipDWF · Traditional | 02/07/2001SE |
| K994171 | Medtronic Aortocoronary Shunt and Separately Packaged Arteriotomy CannulaeDWF · Traditional | 04/27/2000SE |
| K000274 | Eopa Elongated One-Piece Arterial Cannula with GuidewireDWF · Special | 02/10/2000SE |
Questions and answers
When was 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524 cleared by the FDA?
24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524 (K012143) received a 510(k) decision of Substantially Equivalent on October 24, 2001, 106 days after the submission was received.
What is the product code of K012143?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.