ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
FDA 510(k) clearance K080067 · decided 2008-07-18
Clearance details
- K-number
- K080067
- Device name
- ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
- Applicant
- Iscience Interventional
- Decision
- Substantially Equivalent
- Date received
- 2008-01-10
- Decision date
- 2008-07-18
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- MPA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. In recall (Z-2590-2014) | Ellex iScience, Inc. | 2014-09-04 |