FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERCUTANEOUS ENTRY NEEDLE, SELDINGER
K Number: K813461
·
Decision Dec 29, 1981
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
9
Review Days
18
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Basic Information
- Device Name
- PERCUTANEOUS ENTRY NEEDLE, SELDINGER
- K Number
- K813461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Ocean Medical Products, Ltd.
- Date Received
- December 11, 1981
- Decision Date
- December 29, 1981
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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Other Clearances by Ocean Medical Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K882013 | SOFT TISSUE BIOPSY DEVICE | Jun 15, 1988 | Substantially Equivalent |
| K870896 | NOTCH-NEEDLE, WESCOTT STYLE | Mar 18, 1987 | Substantially Equivalent |
| K843719 | SINGLE WALL INTRODUCER NEEDLE | Oct 18, 1984 | Substantially Equivalent |
| K823693 | MYELOGRAPHY NEEDLE | Feb 7, 1983 | Substantially Equivalent |
| K823692 | SPINAL NEEDLE | Jan 7, 1983 | Substantially Equivalent |
| K813462 | MADAYAG TYPE NEEDLE | Mar 1, 1982 | Substantially Equivalent |
| K813448 | POTTS-COURNAND STYLE NEEDLE | Jan 7, 1982 | Substantially Equivalent |
| K813460 | CHIBA SKINNY NEEDLE | Jan 7, 1982 | Substantially Equivalent |