Navarre Universal Drainage Catheter
FDA 510(k) K951475 · Navarre Biomedical , Ltd.
510(k) numberK951475
Submission
- Device name
- Navarre Universal Drainage Catheter
- Applicant
- Navarre Biomedical , Ltd.
Plymouth, MN, US - Received
- March 30, 1995
- Decision date
- April 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | Ultracell Medical Technologies, Inc. | 10/01/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
More from Axiom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955110 | Navarre Percutaneous Biliary DrainageFGE · Traditional | 11/07/1996SE |
| K955505 | Opti-Drain Multi-Use Drainage CatheterGBX · Traditional | 02/07/1996SE |
| K945909 | Navarre N-Fuser(Tm) Peripheral Infusion CatheterKRA · Traditional | 06/02/1995SE |
| K951907 | Navarre Locking Pigtail Universal Drainage CatheterGBX · Traditional | 05/15/1995SE |
| K943663 | Navarre 600 ML Drainage BagEXF · Traditional | 09/08/1994SE |
| K942315 | Navarre Percutaneous Access SetKGZ · Traditional | 07/08/1994SE |
| K933600 | Navarre Biomedical Tip-Locking Drainage CathetersGBX · Traditional | 03/28/1994SE |
| K932391 | Navarre Biomedical Universal Drainage Catheter SetGBX · Traditional | 01/27/1994SE |
Questions and answers
When was Navarre Universal Drainage Catheter cleared by the FDA?
Navarre Universal Drainage Catheter (K951475) received a 510(k) decision of Substantially Equivalent on April 24, 1995, 25 days after the submission was received.
What is the product code of K951475?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.