Tapered Tip the Guider Coronary Guiding Catheter
FDA 510(k) K903217 · Intec Medical, Inc.
510(k) numberK903217
Submission
- Device name
- Tapered Tip the Guider Coronary Guiding Catheter
- Applicant
- Intec Medical, Inc.
Danvers, MA, US - Received
- July 23, 1990
- Decision date
- October 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
|---|---|---|
| K911840 | Interflo Medical Model PA3-H Cco/Pac CatheterDYG · Traditional | 06/03/1991SE |
| K903216 | The Guider Coronary Guiding CatheterDQY · Traditional | 10/19/1990SE |
| K900710 | Interflo Medical Model F-1 Thermodilution CatheterKRB · Traditional | 10/19/1990SE |
| K903840 | Giant Lumen Safetip Series: Endomyocardial BiopsyDYB · Traditional | 10/16/1990SE |
| K903906 | Percutaneous Catheter Introducer KitDYB · Traditional | 09/26/1990SE |
| K900998 | Interventional Medical Y Adapter W/Adjust. ValveDQY · Traditional | 08/14/1990SE |
| K901247 | Tri Adapter W/Adjustable Hemostasis ValvesDYG · Traditional | 07/31/1990SE |
| K894925 | Amcath Ureteral Dilators Models 7100,7110,7120EZN · Traditional | 12/13/1989SE |
| K860941 | Disposable Heated Wire Loops 48 and 72BZE · Traditional | 04/02/1986SE |
| K823271 | Disposable Adult Vo. Ventilator CircuitBZO · Traditional | 12/22/1982SE |
Questions and answers
When was Tapered Tip the Guider Coronary Guiding Catheter cleared by the FDA?
Tapered Tip the Guider Coronary Guiding Catheter (K903217) received a 510(k) decision of Substantially Equivalent on October 19, 1990, 88 days after the submission was received.
What is the product code of K903217?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.