Byrd Telescoping Stainless Steel Dilat Sheath Set
FDA 510(k) K922354 · Med Institute, Inc.
510(k) numberK922354
Submission
- Device name
- Byrd Telescoping Stainless Steel Dilat Sheath Set
- Applicant
- Med Institute, Inc.
West Lafayette, IN, US - Received
- May 19, 1992
- Decision date
- July 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCC – Dilator, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GCC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K981061 | Intravascular Retrieval DeviceGCC · Traditional | Med Institute, Inc. | 05/26/1998SE |
| K902502 | Byrd Stainless Steel DilatorGCC · Traditional | Medical Engineering and Development Institute | 08/07/1990SE |
| K893480 | Byrd Extractor SetGCC · Traditional | Medical Engineering and Development Institute | 06/23/1989SE |
| K820865 | Van-Tec Fascial DilatorGCC · Traditional | Van-Tec, Inc. | 05/05/1982SE |
More from Van-Tec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990034 | Wilson-Cook Colonic Z-StentMQR · Traditional | 04/17/2000SE |
| K982507 | Mini Polyurethane CatheterLJT · Traditional | 09/16/1998SE |
| K981061 | Intravascular Retrieval DeviceGCC · Traditional | 05/26/1998SE |
| K964001 | Swartz Doppler Flow Probe and Monitor SystemITX · Traditional | 04/17/1998SE |
| K971140 | Vital-Port Infusion PalLJT · Traditional | 11/17/1997SE |
| K970442 | Target Vital-Port Vascular Access SystemLJT · Traditional | 04/30/1997SE |
| K945586 | Flexible Dilating SheathDRE · Traditional | 04/04/1997SE |
| K960698 | Non-Coring NeedleFMI · Traditional | 04/15/1996SE |
| K941228 | Endoluminal Access TubeKNT · Traditional | 09/27/1995SESK |
| K951077 | Vital-Port Petiet Polysulfone Vascular Access SystemLJT · Traditional | 07/31/1995SE |
Questions and answers
When was Byrd Telescoping Stainless Steel Dilat Sheath Set cleared by the FDA?
Byrd Telescoping Stainless Steel Dilat Sheath Set (K922354) received a 510(k) decision of Substantially Equivalent on July 30, 1992, 72 days after the submission was received.
What is the product code of K922354?
The FDA product code is GCC – Dilator, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.