FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCANLAN SINGLE-USE AORTA PUNCH
K Number: K823764
·
Decision Mar 24, 1983
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
19
Review Days
100
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Basic Information
- Device Name
- SCANLAN SINGLE-USE AORTA PUNCH
- K Number
- K823764
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Scanlan Intl., Inc.
- Date Received
- December 14, 1982
- Decision Date
- March 24, 1983
- 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 Scanlan Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960372 | SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM | Apr 26, 1996 | Substantially Equivalent |
| K945474 | SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER | Dec 5, 1994 | Substantially Equivalent |
| K911184 | SCANLAN/TAHERI VALVULOTOME | Feb 18, 1992 | Substantially Equivalent |
| K864920 | SCANLAN (TM) INSTRUMENT TRAY | Jan 12, 1987 | Substantially Equivalent |
| K864919 | SCANLAN (TM) VEIN/GRAFT HOLDER | Jan 12, 1987 | Substantially Equivalent |
| K851825 | SCANLAN TUNNELER, SHEATH & TIP | Jul 12, 1985 | Substantially Equivalent |
| K841521 | SCANLAN ENDARSECTOR | Aug 3, 1984 | Substantially Equivalent |
| K841513 | SCANLAN ATRAUM INSTRUMENT JAW COVER | Jul 6, 1984 | Substantially Equivalent |
| K841085 | SCANLAN COLORMARK SKIN MARKER | Jun 11, 1984 | Substantially Equivalent |
| K841515 | SCANLAN VASCU-STATT II | Jun 5, 1984 | Substantially Equivalent |