van Andel Dilatation Catheter
FDA 510(k) K170616 · Cook Incorporated
510(k) numberK170616
Submission
- Device name
- van Andel Dilatation Catheter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- March 1, 2017
- Decision date
- April 28, 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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| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
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| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
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| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | 12/12/2019SE |
| K191163 | Lumax Guiding CatheterDQY · Traditional | 12/12/2019SE |
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Questions and answers
When was van Andel Dilatation Catheter cleared by the FDA?
van Andel Dilatation Catheter (K170616) received a 510(k) decision of Substantially Equivalent on April 28, 2017, 58 days after the submission was received.
What is the product code of K170616?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.