Schneider-Shiley Angioport(Tm) Ptca Intro W/Hemo
FDA 510(k) K873195 · Angiomedics, Inc.
510(k) numberK873195
Submission
- Device name
- Schneider-Shiley Angioport(Tm) Ptca Intro W/Hemo
- Applicant
- Angiomedics, Inc.
Minneapolis, MN, US - Received
- August 14, 1987
- Decision date
- December 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K872542 | Schneider-Shiley Softrac-Pta(Tm) Angio. CatheterLIT · Traditional | 09/14/1987SE |
| K872472 | Schneider-Shiley Biflator Balloon Inflation DeviceDXT · Traditional | 09/14/1987SE |
| K863342 | Softip Coronary Sinus Cardioplegia CatheterDWF · Traditional | 03/03/1987SE |
| K861238 | Angiomedics Cath Sheath Introduc W/Hemostasis ValvDYB · Traditional | 07/16/1986SE |
| K852872 | Angiomedics Softip CatheterDQO · Traditional | 10/11/1985SE |
| K850271 | Angiomedic's Catheter-Diagnostic IntravascularDQO · Traditional | 04/03/1985SE |
| K834275 | Softip CatheterDQO · Traditional | 02/04/1984SE |
Questions and answers
When was Schneider-Shiley Angioport(Tm) Ptca Intro W/Hemo cleared by the FDA?
Schneider-Shiley Angioport(Tm) Ptca Intro W/Hemo (K873195) received a 510(k) decision of Substantially Equivalent on December 15, 1987, 123 days after the submission was received.
What is the product code of K873195?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.