Medtronic Gciii Coronary Guiding Catheter
FDA 510(k) K935738 · Medtronics Interventional Vascular
510(k) numberK935738
Submission
- Device name
- Medtronic Gciii Coronary Guiding Catheter
- Applicant
- Medtronics Interventional Vascular
Danvers, MA, US - Received
- December 1, 1993
- Decision date
- May 4, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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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 |
Questions and answers
When was Medtronic Gciii Coronary Guiding Catheter cleared by the FDA?
Medtronic Gciii Coronary Guiding Catheter (K935738) received a 510(k) decision of Substantially Equivalent on May 4, 1994, 154 days after the submission was received.
What is the product code of K935738?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.