Submission Details
| 510(k) Number | K142914 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 07, 2014 |
| Decision Date | January 12, 2015 |
| Days to Decision | 97 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
DacryoCATH
Jan 2015
Decision
97d
Days
—
Risk
About This 510(k) Submission
K142914 is an FDA 510(k) clearance for the DacryoCATH, a Lacrimal Stents And Intubation Sets, submitted by Armadillo Biomedical, LLC (Encino, US). The FDA issued a Cleared decision on January 12, 2015, 97 days after receiving the submission on October 7, 2014. This device falls under the Ophthalmic review panel.
Device Classification
| Product Code | OKS — Lacrimal Stents And Intubation Sets |
| Device Class | — |
| Definition | Lacrimal Stents And Intubations Sets Are Intended To Repair The Lacrimal Drainage System. Lacrimal Stents And Intubations Sets Are Indicated For, But Limited To, The Treatment Of Epiphora In Infants And Adults; Canalicular Pathologies Such As Stenosis; Obstruction Or Laceration; And Conditions Requiring Dacryocystorhinostomy (conventional Or Laser); Or Imperforation Of The Nasolacrimal Duct In An Infant. |
Manufacturer
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