Angiomedic's Catheter-Diagnostic Intravascular
FDA 510(k) K850271 · Angiomedics, Inc.
510(k) numberK850271
Submission
- Device name
- Angiomedic's Catheter-Diagnostic Intravascular
- Applicant
- Angiomedics, Inc.
Minneapolis, MN, US - Received
- January 23, 1985
- Decision date
- April 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| 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 |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K873195 | Schneider-Shiley Angioport(Tm) Ptca Intro W/HemoDYB · Traditional | 12/15/1987SE |
| 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 |
| K834275 | Softip CatheterDQO · Traditional | 02/04/1984SE |
Questions and answers
When was Angiomedic's Catheter-Diagnostic Intravascular cleared by the FDA?
Angiomedic's Catheter-Diagnostic Intravascular (K850271) received a 510(k) decision of Substantially Equivalent on April 3, 1985, 70 days after the submission was received.
What is the product code of K850271?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.