FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYO/CLIP
K Number: K821518
·
Decision Jul 8, 1982
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
10
Review Days
48
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Basic Information
- Device Name
- MYO/CLIP
- K Number
- K821518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Alto Development Corp.
- Date Received
- May 21, 1982
- Decision Date
- July 8, 1982
- Product Code
- LDF
- 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 |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | FDA class 2 | Cardiovascular |
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Other Clearances by Alto Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K964621 | A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON | Dec 20, 1996 | Substantially Equivalent |
| K932513 | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | Jan 7, 1994 | Substantially Equivalent |
| K931537 | A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT | Sep 7, 1993 | Substantially Equivalent |
| K930528 | A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS | May 17, 1993 | Substantially Equivalent |
| K914193 | A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT | Oct 5, 1992 | Substantially Equivalent |
| K915300 | A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES | Feb 18, 1992 | Substantially Equivalent |
| K884783 | RANEY CLIP | Nov 30, 1988 | Substantially Equivalent |
| K881413 | ELECTRO-CAUTERY SUCTION TUBE | Apr 21, 1988 | Substantially Equivalent |
| K831867 | PRESSURE MONITORING IV BOTTLE CAP | Aug 12, 1983 | Substantially Equivalent |