FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K Number: K992174
·
Decision Mar 23, 2000
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
5
Review Days
269
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Basic Information
- Device Name
- PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
- K Number
- K992174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pilling Weck Surgical
- Date Received
- June 28, 1999
- Decision Date
- March 23, 2000
- Product Code
- DXC
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | FDA class 2 | Cardiovascular |
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Other Clearances by Pilling Weck Surgical
| K Number | Device Name | ||
|---|---|---|---|
| K992476 | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS | Sep 13, 2000 | Substantially Equivalent |
| K990935 | JACKSON ESOPHAGEAL DILATOR | May 17, 1999 | Substantially Equivalent |
| K990561 | OPTICAL FORCEPS | May 14, 1999 | Substantially Equivalent |
| K982128 | SHIKANI-FRENCH SPEAKING VALVE | Oct 23, 1998 | Substantially Equivalent |