Byrd Dilator Sheath Set - Teflon
FDA 510(k) K902469 · Medical Engineering and Development Institute
510(k) numberK902469
Submission
- Device name
- Byrd Dilator Sheath Set - Teflon
- Applicant
- Medical Engineering and Development Institute
West Lafayette, IN, US - Received
- June 4, 1990
- Decision date
- August 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
Other 510(k)s with product code DRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
More from Xcardia Innovation , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K902477 | Workstation Femoral Intravascular Retrieval SetDYB · Traditional | 08/24/1990SE |
| 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 Byrd Dilator Sheath Set - Teflon cleared by the FDA?
Byrd Dilator Sheath Set - Teflon (K902469) received a 510(k) decision of Substantially Equivalent on August 23, 1990, 80 days after the submission was received.
What is the product code of K902469?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.