Medtronic Angiographic Catheter
FDA 510(k) K980973 · Medtronics Interventional Vascular
510(k) numberK980973
Submission
- Device name
- Medtronic Angiographic Catheter
- Applicant
- Medtronics Interventional Vascular
Danvers, MA, US - Received
- March 16, 1998
- Decision date
- December 10, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
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| K972944 | Medtronic Mustang Super Floppy Guide Wire/Floppy Guide Wire/Intermediate Guide…DQX · Traditional | 11/03/1997SE |
| K961917 | Medtronic Mustang Steerable Guide Wire (M-45FR, M45FX)DQX · Traditional | 11/20/1996SE |
| K960983 | Medtronic Everst 30 Inflation Device/Survival KitMAV · Traditional | 05/30/1996SE |
| K955651 | Medtronic Sherpa Guiding CatheterDQY · Traditional | 01/22/1996SE |
| K950490 | Medtronic GC IV Coronary Guiding CatheterDQY · Traditional | 11/21/1995SE |
| K950179 | Medtronic(R) GC III Coronary Guiding CatheterDQY · Traditional | 07/25/1995SE |
| K950026 | Medtronic(R) 8.2 French Sherpa(R) Super Peak Flow(Tm) Coronary Guiding CatheterDQY · Traditional | 04/05/1995SE |
Questions and answers
When was Medtronic Angiographic Catheter cleared by the FDA?
Medtronic Angiographic Catheter (K980973) received a 510(k) decision of Substantially Equivalent on December 10, 1998, 269 days after the submission was received.
What is the product code of K980973?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.