FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTINUOUS FLUSH DEVICE
K Number: K792141
·
Decision Dec 5, 1979
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
170
Applicant Total
24
Review Days
44
Basic Information
- Device Name
- CONTINUOUS FLUSH DEVICE
- K Number
- K792141
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
- Date Received
- October 22, 1979
- Decision Date
- December 5, 1979
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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Other Clearances by PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K792369 | HYPERALIMENTATION DRESSING TRAY | Dec 10, 1979 | Substantially Equivalent |
| K792019 | PHADECODE XA INHIBITOR ASSAY | Nov 5, 1979 | Substantially Equivalent |
| K791773 | VENTILATOR TUBE WITH FILTER | Oct 22, 1979 | Substantially Equivalent |
| K791156 | AMIPAQUE MYELOGRAM TRAY | Jul 30, 1979 | Substantially Equivalent |
| K790896 | TWO-WAY ANESTHESIA FILTER | Jun 5, 1979 | Substantially Equivalent |
| K790409 | LOW DEAD SPACE INSULIN SYRINGE | Apr 24, 1979 | Substantially Equivalent |
| K782069 | TRAY, AUXILLARY BLOCK | Jan 4, 1979 | Substantially Equivalent |
| K781797 | PREP TRAY, PREOPERATIVE SKIN | Nov 8, 1978 | Substantially Equivalent |
| K781680 | MONITORING, PRESSURE KIT | Oct 6, 1978 | Substantially Equivalent |
| K780887 | IMPROVED DISPOSABLE HYPODERMIC NEEDLE | Jun 22, 1978 | Substantially Equivalent |