Needles Used in Angiographic Proced.
FDA 510(k) K772369 · Argon Medical Corp.
510(k) numberK772369
Submission
- Device name
- Needles Used in Angiographic Proced.
- Applicant
- Argon Medical Corp.
Mchenry, IL, US - Received
- December 27, 1977
- Decision date
- January 24, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
|---|---|---|
| K130730 | V-Stick Vascular Access SetDYB · Special | 11/22/2013SE |
| K904994 | Closed System Flush SetDXT · Traditional | 01/15/1991SE |
| K895511 | Catheter Balloon Dilator Pressure GaugeMAV · Traditional | 02/28/1990SE |
| K894157 | ObturatorDYB · Traditional | 09/28/1989SE |
| K891022 | Introducer for Ptca Guiding CathetersDYB · Traditional | 05/19/1989SE |
| K884375 | Translumbar Aortography Needle CatheterDQR · Traditional | 01/11/1989SE |
| K882221 | Over the Needle Catheter, Arterial Catheter NeedleDYB · Traditional | 08/12/1988SE |
| K871297 | Kadir Hi-Torque Guide WireKOD · Traditional | 04/10/1987SE |
| K853312 | Argon Cut Biopsy Needles, Various SizesDWO · Traditional | 09/12/1985SE |
| K852880 | Peel-Away Sheath(A Component of Argon Introd Set)DYB · Traditional | 08/29/1985SE |
Questions and answers
When was Needles Used in Angiographic Proced. cleared by the FDA?
Needles Used in Angiographic Proced. (K772369) received a 510(k) decision of Substantially Equivalent on January 24, 1978, 28 days after the submission was received.
What is the product code of K772369?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.