DACRYOCATH
FDA 510(k) clearance K113508 · decided 2012-08-31
Clearance details
- K-number
- K113508
- Device name
- DACRYOCATH
- Applicant
- Armadillo Biomedical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-11-28
- Decision date
- 2012-08-31
- Days to decision
- 277 days
- Clearance type
- Traditional
- Product code
- OKS
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| DacryoCATH (K142914) | Armadillo Biomedical, LLC | 2015-01-12 |
| STOPLOSS JONES TUBE (K140290) | Ljt Surgical, Ltd. | 2014-12-02 |
| SELF-RETAINING BICANALICULUS INTUBATON SET II (K130375) | Fci Sas (France Chirurgie Instrumentation) | 2013-12-04 |
| OPHTACATH KIT (K123831) | France Chirurgae Instrumentation | 2013-07-29 |
| LACRIFAST (K120886) | Hiroyasu Higuchi | 2012-12-17 |
| DCS LACRIMAL STENT (K113316) | Dcs Surgical, Inc. | 2012-11-08 |
| LACRICATH LACRIMAL DUCT CATHETER (K113867) | Quest Medical, Inc. | 2012-10-19 |
Recalls involving this device
No recalls on record reference this clearance.