FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERITONEAL CYCLER & MANIFOLD SET
K Number: K772136
·
Decision Dec 20, 1977
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
112
Applicant Total
80
Review Days
36
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Basic Information
- Device Name
- PERITONEAL CYCLER & MANIFOLD SET
- K Number
- K772136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Physio-Control Corp.
- Date Received
- November 14, 1977
- Decision Date
- December 20, 1977
- Product Code
- KDJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | FDA class 2 | Gastroenterology, Urology |
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staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
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Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
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Other Clearances by Physio-Control Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K991910 | LIFEPAK 12 BIPHASIC | Sep 3, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K990338 | NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM | Sep 1, 1999 | Substantially Equivalent |
| K983393 | LIFEPAK 500 BIPHASIC | May 5, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K973486 | LIFE PAK 12 | Jan 9, 1998 | Substantially Equivalent |
| K962359 | LIFEPAK 300 | Nov 6, 1997 | Substantially Equivalent |
| K955854 | LIFEPAK 500 | Nov 4, 1996 | Substantially Equivalent |
| K953204 | PEDIATRIC QUIK-COMBO | Jan 11, 1996 | Substantially Equivalent |
| K951593 | LIFEPAK 11 | Dec 29, 1995 | Substantially Equivalent |
| K945511 | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR | Sep 26, 1995 | Substantially Equivalent |
| K943301 | QUIK COMBO | Feb 3, 1995 | Substantially Equivalent |