Navigator Delivery System (Navigator DS)
FDA 510(k) K120830 · Carticept Medical, Inc.
510(k) numberK120830
Submission
- Device name
- Navigator Delivery System (Navigator DS)
- Applicant
- Carticept Medical, Inc.
Alpharetta, GA, US - Received
- March 19, 2012
- Decision date
- April 16, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K151255 | Navigator Aesthetic Delivery SystemFRN · Traditional | 12/30/2015SE |
| K124053 | Navigator Delivery System (Navigator DS)FRN · Special | 03/13/2013SE |
| K122215 | Navigator Delivery System (Navigator DS)FRN · Special | 10/26/2012SE |
| K112067 | Navigator Delivery System (Navigator DS)FRN · Traditional | 09/16/2011SE |
| K101194 | Navigator Delivery System (or Navigator DS) Model: NAV-010FRN · Traditional | 07/11/2011SE |
Questions and answers
When was Navigator Delivery System (Navigator DS) cleared by the FDA?
Navigator Delivery System (Navigator DS) (K120830) received a 510(k) decision of Substantially Equivalent on April 16, 2012, 28 days after the submission was received.
What is the product code of K120830?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.