Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic Therapy Pak, Model 12000 Series
FDA 510(k) K000457 · Retinalabs.Com
510(k) numberK000457
Submission
- Device name
- Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic Therapy Pak, Model 12000 Series
- Applicant
- Retinalabs.Com
Atlanta, GA, US - Received
- February 11, 2000
- Decision date
- May 9, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HMX – Cannula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HMX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010305 | Weiss Retinal CannulaHMX · Traditional | Micron Surgical, Inc. | 05/02/2001SE |
| K970873 | Endosoft Soft Tip Needle (20 Ga. and 19 Ga.)HMX · Traditional | American Medical Devices, Inc. | 05/20/1997SE |
| K943932 | Steriseal Ophthalmic CannulaHMX · Traditional | Pharma-Plast, Ltd. | 01/18/1995SE |
| K942403 | Infusion CannulaHMX · Traditional | Microsurgical Technology, Inc. | 08/17/1994SE |
| K934844 | Inter Tip THMX · Traditional | Microsurgical Technology, Inc. | 04/19/1994SE |
| K930113 | Kirwan Irrigation/Aspiration HandpieceHMX · Traditional | Kirwan Surgical Products, Inc. | 02/17/1994SE |
| K921488 | Aspirating Endo Ocular Probe W/IlluminationHMX · Traditional | Surgical Technologies, Inc. | 05/07/1992SE |
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | Biomedical Dynamics, Inc. | 02/05/1992SE |
| K904074 | Vitreoretinal Infusion CannulaHMX · Traditional | Visitec Co. | 02/26/1991SE |
| K901618 | Ocular Infusion Cannula SystemHMX · Traditional | Tamcenan Corp. | 05/31/1990SE |
More from Tamcenan Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K003036 | Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model…KYG · Traditional | 12/22/2000SE |
| K000418 | PDT Dosecalculator, Model 80000NDC · Traditional | 10/24/2000SE |
| K000420 | Silicone Oil Express (Infusion Pak), Models 10000, 10001, 10002, 10003MRH · Traditional | 05/08/2000SE |
| K000416 | Transpak (Vitreoretinal Infusion Pak), Models 90000, 90001MPA · Traditional | 05/08/2000SE |
Questions and answers
When was Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic Therapy Pak, Model 12000 Series cleared by the FDA?
Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic Therapy Pak, Model 12000 Series (K000457) received a 510(k) decision of Substantially Equivalent on May 9, 2000, 88 days after the submission was received.
What is the product code of K000457?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.