FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
K Number: K980016
·
Decision Aug 7, 1998
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
9
Review Days
217
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Basic Information
- Device Name
- MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
- K Number
- K980016
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.3935
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
- Date Received
- January 2, 1998
- Decision Date
- August 7, 1998
- Product Code
- MOP
- 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 |
|---|---|---|---|
| MOP | Rotator, Prosthetic Heart Valve | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOP), ordered by most recent decision date.
SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
FDA 510(k)
FDA Class 1
·Cardiovascular
CARBOMEDICS MITRAL ROTATOR
FDA 510(k)
FDA Class 1
·Cardiovascular
CARBOMEDICS EXENDED MITRAL ROTATOR
FDA 510(k)
FDA Class 1
·Cardiovascular
Other Clearances by Genzyme Surgical Product (Genzyme Biosurgery)
| K Number | Device Name | ||
|---|---|---|---|
| K001440 | NEXTSTITCH CARDIOVASCULAR VALVE SUTURE | Nov 13, 2000 | Substantially Equivalent |
| K001434 | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE | Jun 12, 2000 | Substantially Equivalent for Some Indications |
| K992088 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE | Sep 3, 1999 | Substantially Equivalent |
| K991416 | ENDOSCOPIC CAMERA | Jul 20, 1999 | Substantially Equivalent |
| K991191 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE | Jun 22, 1999 | Substantially Equivalent |
| K990062 | SAPHLIFT | Mar 30, 1999 | Substantially Equivalent |
| K982712 | RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 | Dec 18, 1998 | Substantially Equivalent |
| K981322 | CUTALON NYLON POLYAMIDE SURGICAL SUTURE | Jul 7, 1998 | Substantially Equivalent |