FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROFUSE INFUSION SYSTEM
K Number: K912877
·
Decision Sep 23, 1991
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
42
Review Days
84
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Basic Information
- Device Name
- PROFUSE INFUSION SYSTEM
- K Number
- K912877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lake Region Mfg., Inc.
- Date Received
- July 1, 1991
- Decision Date
- September 23, 1991
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Lake Region Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K092965 | TRAILRUNNER GUIDEWIRES | Feb 26, 2010 | Substantially Equivalent |
| K082922 | FREEWAY AND RAILRUNNER GUIDEWIRES | Dec 9, 2008 | Substantially Equivalent |
| K081708 | TAXI ENDOSCOPIC GUIDEWIRE | Aug 26, 2008 | Substantially Equivalent |
| K080144 | MANDREL GUIDEWIRES OR M-WIRES | Feb 26, 2008 | Substantially Equivalent |
| K073655 | PEGASUS STEERABLE (PTCA) GUIDEWIRE | Jan 28, 2008 | Substantially Equivalent |
| K060454 | TITAN GUIDEWIRE | Mar 24, 2006 | Substantially Equivalent |
| K052347 | TITAN STEERABLE (PTCA) GUIDEWIRE | Feb 17, 2006 | Substantially Equivalent |
| K042338 | CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE | Sep 16, 2004 | Substantially Equivalent |
| K041624 | PTCA STEERABLE HYDROPHILIC GUIDEWIRE | Jul 16, 2004 | Substantially Equivalent |
| K040825 | LAKE REGION HYDROPHILIC GUIDEWIRE | May 17, 2004 | Substantially Equivalent |