Vertex Percutaneous Catheter Introduc
FDA 510(k) K840017 · Professional Medical Services
510(k) numberK840017
Submission
- Device name
- Vertex Percutaneous Catheter Introduc
- Applicant
- Professional Medical Services
Mchenry, IL, US - Received
- January 4, 1984
- Decision date
- February 4, 1984
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K913094 | Disposable Slide Valve ManifoldDQO · Traditional | 01/27/1992SE |
| K910378 | Pressure Monitoring Extension LineDQO · Traditional | 04/22/1991SE |
| K904508 | Condor Analog Inflation SyringeMAV · Traditional | 04/02/1991SE |
| K904954 | Condor Digital Inflation SyringeMAV · Traditional | 01/16/1991SE |
| K902606 | Radiopaque RulerKPR · Traditional | 09/27/1990SE |
| K884577 | Procedure Ready TraysFOZ · Traditional | 08/01/1989SESD |
| K890471 | PMS Angio DrapeKKX · Traditional | 02/27/1989SE |
| K884497 | Control SyringeFMF · Traditional | 12/12/1988SE |
| K872448 | Blood Containment PackLRO · Traditional | 11/17/1987SE |
| K864555 | 3 Ring AttachmentFMF · Traditional | 12/01/1986SE |
Questions and answers
When was Vertex Percutaneous Catheter Introduc cleared by the FDA?
Vertex Percutaneous Catheter Introduc (K840017) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 31 days after the submission was received.
What is the product code of K840017?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.