Eschmann Dilation Catheter
FDA 510(k) K833742 · Vertex Medical Corp.
510(k) numberK833742
Submission
- Device name
- Eschmann Dilation Catheter
- Applicant
- Vertex Medical Corp.
Walker, MI, US - Received
- October 26, 1983
- Decision date
- April 24, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Vertex Medical Corp.
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|---|---|---|
| K834476 | Nephrostomy/Biliary Drainage BagLJE · Traditional | 02/04/1984SE |
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| K831666 | Sialography Needle · Traditional | 07/12/1983SE |
| K830576 | Lymphangiography SetDQO · Traditional | 03/17/1983SE |
| K830420 | Polyethylene Monitoring ConnectorsDQO · Traditional | 02/28/1983SE |
| K830237 | Translucent Poly. Cath. Connector andDQO · Traditional | 02/18/1983SE |
| 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 Eschmann Dilation Catheter cleared by the FDA?
Eschmann Dilation Catheter (K833742) received a 510(k) decision of Substantially Equivalent on April 24, 1984, 181 days after the submission was received.