Visitec Collar Button Catheter {Griffiths}
FDA 510(k) K953394 · Visitec Co.
510(k) numberK953394
Submission
- Device name
- Visitec Collar Button Catheter {Griffiths}
- Applicant
- Visitec Co.
Sarasota, FL, US - Received
- July 17, 1995
- Decision date
- October 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZU – Plug, Punctum
- Device class
- Unclassified
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| K190210 | Tear Pool Dissolvable Punctum PlugsLZU · Traditional | Alphamed, Inc. | 10/24/2019SE |
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| K161673 | LacriPro Punctum PlugLZU · Traditional | Lacrimedics, Inc. | 11/18/2016SE |
| K150288 | PDO Absorbable Punctum PlugLZU · Traditional | Riverpoint Medical | 08/28/2015SE |
| K140352 | VeraplugLZU · Traditional | Krishna Imports Inc Dba Stephens Instruments | 11/13/2014SE |
| K140711 | Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug…LZU · Traditional | Paragon Bioteck, Inc. | 06/20/2014SE |
| K140026 | Collasyn Plug for the Lacrimal Efficiency TestLZU · Traditional | Lacrimedics, Inc. | 06/03/2014SE |
More from Lacrimedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | 01/17/1995SE |
| K942234 | Visitec Precise-PointGAP · Traditional | 07/12/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
| K923645 | Visitec Aspirating SyringeFMF · Traditional | 09/30/1992SE |
Questions and answers
When was Visitec Collar Button Catheter {Griffiths} cleared by the FDA?
Visitec Collar Button Catheter {Griffiths} (K953394) received a 510(k) decision of Substantially Equivalent on October 12, 1995, 87 days after the submission was received.
What is the product code of K953394?
The FDA product code is LZU – Plug, Punctum, a Unclassified device.