FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STEIGER TUNNELING INSTRUMENT 285
K Number: K840529
·
Decision Mar 12, 1984
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
6
Review Days
33
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Basic Information
- Device Name
- STEIGER TUNNELING INSTRUMENT 285
- K Number
- K840529
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Evermed, Inc.
- Date Received
- February 8, 1984
- Decision Date
- March 12, 1984
- Product Code
- DRC
- 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 |
|---|---|---|---|
| DRC | Trocar | FDA class 2 | Cardiovascular |
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Other Clearances by Evermed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K840846 | STERILE HICHMAN/BROVIAC INJECTION CAP | Jul 6, 1984 | Substantially Equivalent |
| K830406 | NON-STERILE CATHETER REPAIR KITS | Mar 1, 1983 | Substantially Equivalent |
| K830256 | NON-STERILE BROVIAC PARENTERAL ALIMI- | Mar 1, 1983 | Substantially Equivalent |
| K830233 | NON-STERILE,SINGLE/SOUBLE LUMEN-CATH | Feb 28, 1983 | Substantially Equivalent |
| K830257 | NON-STERILE PERITONEAL ACCESS CATHET- | Feb 24, 1983 | Substantially Equivalent |