Exel Indwelling Catheter
FDA 510(k) K895772 · Exel Intl.
510(k) numberK895772
Submission
- Device name
- Exel Indwelling Catheter
- Applicant
- Exel Intl.
Culver City, CA, US - Received
- September 26, 1989
- Decision date
- February 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FDZ – Attachment, Eyepiece, For Insertion Of Prescription Lens
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FDZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852642 | Central Vein Catheterization TrayFDZ · Traditional | Teleflexmedical, Inc. | 01/16/1986SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992290 | Exel Injection Plug with CapFPA · Traditional | 02/23/2000SE |
| K963658 | Exel Avf Single NeedleFMI · Traditional | 05/05/1998SE |
| K963659 | Exel I.V. Administration SetFPA · Traditional | 12/16/1997SE |
| K926119 | Exel Huber Infusion Set Rotating WingFPA · Traditional | 08/11/1993SE |
| K904685 | Exel Huber Infusion Set Without Injection Site (Y)FPA · Traditional | 11/21/1990SE |
| K903945 | Exel A-V Fistula SetFIE · Traditional | 11/20/1990SE |
| K895770 | Exel Huber Infusion SetFPA · Traditional | 07/19/1990SE |
| K895771 | Exel Spinal NeedlesFMI · Traditional | 02/16/1990SE |
| K895769 | Exel Huber NeedleFMI · Traditional | 02/16/1990SE |
| K895768 | Exel Safelet CatheterFOZ · Traditional | 02/16/1990SE |
Questions and answers
When was Exel Indwelling Catheter cleared by the FDA?
Exel Indwelling Catheter (K895772) received a 510(k) decision of Substantially Equivalent on February 16, 1990, 143 days after the submission was received.
What is the product code of K895772?
The FDA product code is FDZ – Attachment, Eyepiece, For Insertion Of Prescription Lens, a Class I (low risk) device regulated under 21 CFR 876.1500.