Vessel Dilator
FDA 510(k) K822595 · Vertex Medical Corp.
510(k) numberK822595
Submission
- Device name
- Vessel Dilator
- Applicant
- Vertex Medical Corp.
Mchenry, IL, US - Received
- August 27, 1982
- Decision date
- September 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
Other 510(k)s with product code DRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
More from Xcardia Innovation , Ltd.
| 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 |
| 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 |
Questions and answers
When was Vessel Dilator cleared by the FDA?
Vessel Dilator (K822595) received a 510(k) decision of Substantially Equivalent on September 28, 1982, 32 days after the submission was received.
What is the product code of K822595?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.