Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
FDA 510(k) K162181 · Cardiacassist, Inc.
510(k) numberK162181
Submission
- Device name
- Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
- Applicant
- Cardiacassist, Inc.
Pittsburgh, PA, US - Received
- August 4, 2016
- Decision date
- January 6, 2017
- 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 |
|---|---|---|
| K233736 | LifeSPARC SystemQNR · Traditional | 01/19/2024SE |
| K232480 | ProtekDuo Veno-Venous Cannula SetsPZS · Traditional | 10/06/2023SE |
| K232132 | LifeSPARC SystemKFM · Special | 08/03/2023SE |
| K211830 | LifeSPARC SystemQNR · Traditional | 11/15/2022SE |
| K202751 | TandemHeart Pump and Escort ControllerQNR · Traditional | 03/26/2021SE |
| K183623 | LifeSPARC Pump, LifeSPARC ControllerKFM · Traditional | 07/09/2019SE |
| K181150 | ProtekDuo Mini Veno-Venous Cannula SetDWF · Special | 05/25/2018SE |
| K162214 | Protek Solo 24 Fr Venous Cannula SetDWF · Traditional | 11/30/2016SE |
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula SetDWF · Special | 03/04/2016SE |
| K153295 | TandemLung OxygenatorDTZ · Traditional | 02/26/2016SE |
Questions and answers
When was Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set cleared by the FDA?
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set (K162181) received a 510(k) decision of Substantially Equivalent on January 6, 2017, 155 days after the submission was received.
What is the product code of K162181?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.