ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER— 510(k) K080067
Substantially EquivalentIscience Interventional
FDA 510(k) clearance K080067 for ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER, Substantially Equivalent on 2008-07-18. Applicant: Iscience Interventional. Device class: 2.
Clearance details
- Applicant
- Iscience Interventional
- Product code
- Code MPA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code MPA
view all- K253468 — Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)
- K242184 — Alcon 27GA Chandelier (8065000252) +2 more
- K233653 — Midfield Light Pipe, 23ga (3269.M06-00) +2 more
- K221872 — ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
- K202670 — Nam illumination probe with chopper
Recalls naming K080067
K-number listed on FDA's recall record- Z-0011-2019 — ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
- Z-2590-2014 — iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080067.
Data sourced from openFDA. This site is unofficial and independent of the FDA.