Navarre Percutaneous Access Set
FDA 510(k) K942315 · Navarre Biomedical , Ltd.
510(k) numberK942315
Submission
- Device name
- Navarre Percutaneous Access Set
- Applicant
- Navarre Biomedical , Ltd.
Hamel, MN, US - Received
- May 13, 1994
- Decision date
- July 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGZ – Accessories, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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More from Cathaid, 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 |
| K951475 | Navarre Universal Drainage CatheterGBX · Traditional | 04/24/1995SE |
| K943663 | Navarre 600 ML Drainage BagEXF · Traditional | 09/08/1994SE |
| 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 Percutaneous Access Set cleared by the FDA?
Navarre Percutaneous Access Set (K942315) received a 510(k) decision of Substantially Equivalent on July 8, 1994, 56 days after the submission was received.
What is the product code of K942315?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.