FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCUTEK VASCULAR PROTHESIS VP1200K/50K
K Number: K830016
·
Decision Dec 21, 1983
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
96
Review Days
352
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VASCUTEK VASCULAR PROTHESIS VP1200K/50K
- K Number
- K830016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Pacesetter Systems
- Date Received
- January 3, 1983
- Decision Date
- December 21, 1983
- Product Code
- DSY
- 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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSY), ordered by most recent decision date.
Fusion Bioline Vascular Graft
FDA 510(k)
FDA Class 2
·Cardiovascular
Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)
FDA 510(k)
FDA Class 2
·Cardiovascular
Gelweave Vascular Prostheses
FDA 510(k)
FDA Class 2
·Cardiovascular
Gelsoft Plus Vascular Prostheses
FDA 510(k)
FDA Class 2
·Cardiovascular
Advanta VXT Vascular Graft, Flixene Vascular Graft
FDA 510(k)
FDA Class 2
·Cardiovascular
GORE® PROPATEN® Vascular Graft
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Pacesetter Systems
| K Number | Device Name | ||
|---|---|---|---|
| K910924 | ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE | Aug 28, 1991 | Substantially Equivalent |
| K902147 | ENDOCARDIAL SCREW-IN LEAD MODEL 1028T | Jul 17, 1990 | Substantially Equivalent |
| K900512 | SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS | Jun 25, 1990 | Substantially Equivalent |
| K900550 | FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T | Apr 20, 1990 | Substantially Equivalent |
| K895447 | ENDOCARDIAL SCREW-IN LEAD MODEL 1020T | Dec 20, 1989 | Substantially Equivalent |
| K891905 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | Jun 5, 1989 | Substantially Equivalent |
| K885267 | VS-1 MODEL NUMBER 251K PULSE GENERATOR | Mar 28, 1989 | Substantially Equivalent |
| K890547 | SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS | Mar 22, 1989 | Substantially Equivalent |
| K884733 | AFP MODEL 262T PULSE GENERATOR | Feb 10, 1989 | Substantially Equivalent |
| K883087 | PROLOG MP 658M PULSE GENERATOR | Sep 14, 1988 | Substantially Equivalent |