FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NAMAN POTTS COURNAND NEEDLE
K Number: K851832
·
Decision Jul 11, 1985
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
20
Review Days
76
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Basic Information
- Device Name
- NAMAN POTTS COURNAND NEEDLE
- K Number
- K851832
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Manan Manufacturing Co., Inc.
- Date Received
- April 26, 1985
- Decision Date
- July 11, 1985
- Product Code
- DWS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | FDA class 1 | Cardiovascular |
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Other Clearances by Manan Manufacturing Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873208 | MANAN TURNER STYLE NEEDLE | Aug 25, 1987 | Substantially Equivalent |
| K864405 | MANAN CONTRAST MEDIA ADMINISTRATION SET | Dec 18, 1986 | Substantially Equivalent |
| K863848 | MANAN BREST TUMOR LOCALIZATION NEEDLE | Oct 14, 1986 | Substantially Equivalent |
| K852501 | MYELOGRAM PROCEDURE TRAY | Jul 11, 1985 | Unknown |
| K851834 | MANAN GWI GUIDE WIRE INTRODUCER | Jul 11, 1985 | Substantially Equivalent |
| K851833 | MANAN SELDINGER NEEDLE | Jul 11, 1985 | Substantially Equivalent |
| K852018 | ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR | Jul 11, 1985 | Unknown |
| K852426 | MANAN TROCAR STYLE BIOPSY NEEDLE | Jun 27, 1985 | Substantially Equivalent |
| K852427 | MANAN SPINAL NEEDLE | Jun 27, 1985 | Substantially Equivalent |
| K852428 | MANAN EPIDURAL NEEDLE | Jun 27, 1985 | Substantially Equivalent |