Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM
FDA 510(k) K120086 · Cardiosolutions
510(k) numberK120086
Submission
- Device name
- Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM
- Applicant
- Cardiosolutions
West Bridgewater, MA, US - Received
- January 11, 2012
- Decision date
- April 24, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRA – Catheter, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1280
- Specialty
- Cardiovascular
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| K233248 | FARADRIVE Steerable SheathDRA · Traditional | Boston Scientific Corporation | 12/11/2023SE |
| K232321 | FlexCath Contour Steerable SheathDRA · Traditional | Medtronic, Inc. | 10/31/2023SE |
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| K221397 | MitraClip G4 Steerable Guide CatheterDRA · Special | Abbott Medical | 09/28/2022SE |
| K221044 | AcQGuide® VUE Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/05/2022SE |
| K211100 | AcQGuide MAX Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/14/2021SE |
| K202620 | FlexCath Advance Steerable Sheath and DilatorDRA · Traditional | Medtronic Cryocath, LP | 11/13/2020SE |
| K192422 | Steerable Introducer 12FDRA · Traditional | Freudenberg Medical, LLC | 10/04/2019SE |
More from Freudenberg Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K140015 | Cardiosolutions Dexterity Steerable IntroducerDYB · Special | 02/05/2014SE |
| K131332 | Cardiosolutions Percu-Pro Steerable IntroducerDYB · Special | 07/19/2013SE |
| K094048 | Percupro Messenger Balloon CatheterDYG · Traditional | 07/14/2011SE |
| K094062 | Percu-Pro GuidewireDQX · Traditional | 09/27/2010SE |
Questions and answers
When was Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM cleared by the FDA?
Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable Introducer 80CM (K120086) received a 510(k) decision of Substantially Equivalent on April 24, 2012, 104 days after the submission was received.
What is the product code of K120086?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.