Translucent Poly. Cath. Connector and
FDA 510(k) K830237 · Vertex Medical Corp.
510(k) numberK830237
Submission
- Device name
- Translucent Poly. Cath. Connector and
- Applicant
- Vertex Medical Corp.
Mchenry, IL, US - Received
- January 25, 1983
- Decision date
- February 18, 1983
- 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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|---|---|---|---|
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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 |
|---|---|---|
| K833742 | Eschmann Dilation Catheter · Traditional | 04/24/1984SE |
| K834476 | Nephrostomy/Biliary Drainage BagLJE · Traditional | 02/04/1984SE |
| K832380 | Protective SleeveDYG · Traditional | 11/28/1983SE |
| K831666 | Sialography Needle · Traditional | 07/12/1983SE |
| K830576 | Lymphangiography SetDQO · Traditional | 03/17/1983SE |
| K830420 | Polyethylene Monitoring ConnectorsDQO · Traditional | 02/28/1983SE |
| K823340 | Clear Vinyl Monitoring ConnectorDXT · Traditional | 12/30/1982SE |
| K823256 | Ultra-Asept Angiographic Syringe/SpareDXT · Traditional | 12/30/1982SE |
| K823254 | Reusable Metal StopcockDXT · Traditional | 12/30/1982SE |
| K823253 | Vertex Monitoring CatheterDXT · Traditional | 12/30/1982SE |
Questions and answers
When was Translucent Poly. Cath. Connector and cleared by the FDA?
Translucent Poly. Cath. Connector and (K830237) received a 510(k) decision of Substantially Equivalent on February 18, 1983, 24 days after the submission was received.
What is the product code of K830237?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.