Naman Potts Cournand Needle
FDA 510(k) K851832 · Manan Manufacturing Co., Inc.
510(k) numberK851832
Submission
- Device name
- Naman Potts Cournand Needle
- Applicant
- Manan Manufacturing Co., Inc.
Skokie, IL, US - Received
- April 26, 1985
- Decision date
- July 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
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| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | Contour Fabricators of Florida, Inc. | 05/15/1996SE |
| K960139 | G.E. Sterile Angiographic TrayDWS · Traditional | GE Medical Systems | 04/19/1996SESK |
| K960144 | G.E. Sterile CT Biopsy TrayDWS · Traditional | GE Medical Systems | 04/15/1996SESK |
| K960143 | G.E. Sterile Digital Angiographic TrayDWS · Traditional | GE Medical Systems | 04/09/1996SESK |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873208 | Manan Turner Style NeedleKNW · Traditional | 08/25/1987SE |
| K864405 | Manan Contrast Media Administration SetFPA · Traditional | 12/18/1986SE |
| K863848 | Manan Brest Tumor Localization NeedleGAA · Traditional | 10/14/1986SE |
| K852501 | Myelogram Procedure Tray · Traditional | 07/11/1985SESD |
| K852018 | Arthrogram Tray for Double & Single Contrast Arthr · Traditional | 07/11/1985SESD |
| K851834 | Manan Gwi Guide Wire IntroducerDWS · Traditional | 07/11/1985SE |
| K851833 | Manan Seldinger NeedleDWS · Traditional | 07/11/1985SE |
| K852428 | Manan Epidural NeedleGCB · Traditional | 06/27/1985SE |
| K852427 | Manan Spinal NeedleGAA · Traditional | 06/27/1985SE |
| K852426 | Manan Trocar Style Biopsy NeedleGAA · Traditional | 06/27/1985SE |
Questions and answers
When was Naman Potts Cournand Needle cleared by the FDA?
Naman Potts Cournand Needle (K851832) received a 510(k) decision of Substantially Equivalent on July 11, 1985, 76 days after the submission was received.
What is the product code of K851832?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.