Insyte Artcath Arterial Catheterization Unit
FDA 510(k) K921845 · Becton Dickinson Vascular Access, Inc.
510(k) numberK921845
Submission
- Device name
- Insyte Artcath Arterial Catheterization Unit
- Applicant
- Becton Dickinson Vascular Access, Inc.
Sandy, UT, US - Received
- April 17, 1992
- Decision date
- November 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
|---|---|---|
| K971339 | Insyte, Insyte-W, Insyte Autoguard CathetersFOZ · Traditional | 12/24/1997SE |
| K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetFPA · Traditional | 04/08/1997SE |
| K964050 | First Midcath CatheterFOZ · Traditional | 01/06/1997SE |
| K964049 | First Midcath Catheter with Dual LumensFOZ · Traditional | 01/06/1997SE |
| K964048 | First Midcath Catheter KitFOZ · Traditional | 01/06/1997SE |
| K954906 | First Picc Introducer CatheterDYB · Traditional | 04/08/1996SE |
| K952861 | Angiocath & Insyte Autoguard CathetersFOZ · Traditional | 07/31/1995SE |
| K952757 | Angiocath, Novbalon, Angio-Set Intravascular & Angiocath Introduction Drainage CatheterFOZ · Traditional | 07/31/1995SE |
| K952053 | E-Z Set, Saf-T E-Z Set, and Minicath Infusion SetsFPA · Traditional | 05/31/1995SE |
| K950301 | Angiocath(R) Nonvalon(R) and Angio-Set(R) IV CathetersFOZ · Traditional | 04/18/1995SE |
Questions and answers
When was Insyte Artcath Arterial Catheterization Unit cleared by the FDA?
Insyte Artcath Arterial Catheterization Unit (K921845) received a 510(k) decision of Substantially Equivalent on November 10, 1992, 207 days after the submission was received.
What is the product code of K921845?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.