Arstasis Dilator Adapter
FDA 510(k) K103421 · Arstasis, Inc.
510(k) numberK103421
Submission
- Device name
- Arstasis Dilator Adapter
- Applicant
- Arstasis, Inc.
San Carlos, CA, US - Received
- November 22, 2010
- Decision date
- May 24, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K151877 | MicroTract Access SystemDRE · Special | 08/07/2015SE |
| K140871 | Axera 2 Access SystemDYB · Special | 06/06/2014SE |
| K140287 | Axera RX Access SystemDYB · Traditional | 05/16/2014SE |
| K140201 | Axera 2 Access SystemDYB · Traditional | 03/28/2014SE |
| K132263 | Axera 2 Access SystemDYB · Special | 08/19/2013SE |
| K123618 | Axera 2 Access SystemDYB · Traditional | 03/24/2013SE |
| K123135 | Axera 2 Access System Model AXE200DYB · Traditional | 01/28/2013SE |
| K121521 | Axera Access SystemDYB · Special | 06/21/2012SE |
| K113110 | Axera Access SystemDYB · Special | 11/09/2011SE |
| K103143 | Arstasis One Latchwire Access SystemDYB · Special | 02/02/2011SE |
Questions and answers
When was Arstasis Dilator Adapter cleared by the FDA?
Arstasis Dilator Adapter (K103421) received a 510(k) decision of Substantially Equivalent on May 24, 2011, 183 days after the submission was received.
What is the product code of K103421?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.