Y-Adapter W/Thouy Borst
FDA 510(k) K895580 · Angeion Corp.
510(k) numberK895580
Submission
- Device name
- Y-Adapter W/Thouy Borst
- Applicant
- Angeion Corp.
Plymouth, MN, US - Received
- September 15, 1989
- Decision date
- April 30, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
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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.
| 510(k) | Device | Decision |
|---|---|---|
| K921757 | Angeion Igital AngeflatorMAV · Traditional | 03/18/1993SE |
| K925533 | Angestat(R) Pericardial Drainage Sheath SetGBX · Traditional | 01/12/1993SE |
| K915719 | Angeion Endoscopic Valve SealODC · Traditional | 02/18/1992SE |
| K902377 | Angeflator(Tm)DXT · Traditional | 12/13/1990SE |
| K894446 | Angeion Hemostasis Valve IntroducerDYB · Traditional | 11/30/1989SE |
| K871153 | Catheter IntroducerDYB · Traditional | 06/24/1987SE |
Questions and answers
When was Y-Adapter W/Thouy Borst cleared by the FDA?
Y-Adapter W/Thouy Borst (K895580) received a 510(k) decision of Substantially Equivalent on April 30, 1990, 227 days after the submission was received.
What is the product code of K895580?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.