FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERFUSOR SECURA SYRINGE PUMP
K Number: K882107
·
Decision Aug 11, 1988
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
9
Review Days
84
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Basic Information
- Device Name
- PERFUSOR SECURA SYRINGE PUMP
- K Number
- K882107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Burron Medical, Inc.
- Date Received
- May 19, 1988
- Decision Date
- August 11, 1988
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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| K Number | Device Name | ||
|---|---|---|---|
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| K896422 | BURRON AMBULATORY DRUG DELIVERY SYSTEM | May 9, 1990 | Substantially Equivalent |
| K884235 | COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT | Mar 6, 1990 | Substantially Equivalent |
| K895191 | ANTI-THROMBOGENIC COATING FOR CATHETERS | Nov 24, 1989 | Substantially Equivalent |
| K895192 | SPINOCAN(R) CONTINUOUS SPINAL TRAY | Sep 18, 1989 | Substantially Equivalent |
| K884183 | BURRON TEFLON-COATED GUIDEWIRE | Aug 3, 1989 | Substantially Equivalent |
| K882106 | PERFUSOR M SYRINGE PUMP | Aug 11, 1988 | Substantially Equivalent |
| K881342 | IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM | Aug 9, 1988 | Substantially Equivalent |