Workstation Femoral Intravascular Retrieval Set
FDA 510(k) K902477 · Medical Engineering and Development Institute
510(k) numberK902477
Submission
- Device name
- Workstation Femoral Intravascular Retrieval Set
- Applicant
- Medical Engineering and Development Institute
West Lafayette, IN, US - Received
- June 4, 1990
- Decision date
- August 24, 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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| 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 |
|---|---|---|
| K902469 | Byrd Dilator Sheath Set - TeflonDRE · Traditional | 08/23/1990SE |
| K902502 | Byrd Stainless Steel DilatorGCC · Traditional | 08/07/1990SE |
| K895030 | Life-Line(Tm) Vascular Access SystemLJT · Traditional | 04/17/1990SESK |
| K893480 | Byrd Extractor SetGCC · Traditional | 06/23/1989SE |
| K890820 | Locking Wire Guide StyletGAD · Traditional | 03/22/1989SE |
Questions and answers
When was Workstation Femoral Intravascular Retrieval Set cleared by the FDA?
Workstation Femoral Intravascular Retrieval Set (K902477) received a 510(k) decision of Substantially Equivalent on August 24, 1990, 81 days after the submission was received.
What is the product code of K902477?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.