GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
FDA 510(k) K152913 · Creganna Medical Aslo Business AS Cregganna Tactx Medical
510(k) numberK152913
Submission
- Device name
- GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
- Applicant
- Creganna Medical Aslo Business AS Cregganna Tactx Medical
Galway, IE - Received
- October 2, 2015
- Decision date
- July 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
More from Protaryx Medical, Inc.
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| K162253 | Trapper Exchange DeviceDQY · Traditional | 01/06/2017SE |
Questions and answers
When was GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle cleared by the FDA?
GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle (K152913) received a 510(k) decision of Substantially Equivalent on July 21, 2016, 293 days after the submission was received.
What is the product code of K152913?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.