Cormed Huber Point Needle
FDA 510(k) K843083 · Cormed, Inc., Sub. C.R.Bard, Inc.
510(k) numberK843083
Submission
- Device name
- Cormed Huber Point Needle
- Applicant
- Cormed, Inc., Sub. C.R.Bard, Inc.
Mchenry, IL, US - Received
- August 6, 1984
- Decision date
- September 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K863606 | Butterfly Non-Coring Needle SetFMI · Traditional | 12/18/1986SE |
| K860432 | Percutaneous Introducer KitDYB · Traditional | 03/31/1986SE |
| K854019 | Port-GardLJT · Traditional | 11/26/1985SE |
| K850967 | Sterile Cormed MediportLJT · Traditional | 05/17/1985SE |
| K850674 | Cormed II Ambulatory Infusion PumpFRN · Traditional | 04/09/1985SE |
| K833915 | Vascular Access Cath. Repair KitLJS · Traditional | 03/30/1984SE |
| K823553 | Corcath H & B Vascular Access CatheterLJS · Traditional | 01/05/1983SE |
Questions and answers
When was Cormed Huber Point Needle cleared by the FDA?
Cormed Huber Point Needle (K843083) received a 510(k) decision of Substantially Equivalent on September 5, 1984, 30 days after the submission was received.
What is the product code of K843083?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.