FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE PERITONEAL DIALYSIS EXTENSION
K Number: K791722
·
Decision Nov 16, 1979
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
112
Applicant Total
30
Review Days
78
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Basic Information
- Device Name
- DISPOSABLE PERITONEAL DIALYSIS EXTENSION
- K Number
- K791722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Medical Products, Inc.
- Date Received
- August 30, 1979
- Decision Date
- November 16, 1979
- 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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Other Clearances by American Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922290 | SINGLE-STEP PREGNANCY, HCG TEST | Jul 9, 1992 | Substantially Equivalent |
| K862221 | E-Z CLEAN | Sep 12, 1986 | Substantially Equivalent |
| K861251 | AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N | Apr 17, 1986 | Substantially Equivalent |
| K830881 | AMPERCIDE DISINFECTANT ACCESSORY TO - | Jun 2, 1983 | Substantially Equivalent |
| K823827 | AMP 80/2 OUTFLOW MONITOR MODIFICATION | Mar 17, 1983 | Substantially Equivalent |
| K822545 | CCPD CYCLER SET W/5 PRONGED CONNECTOR | Oct 13, 1982 | Substantially Equivalent |
| K822546 | SAFE LOCK SEALING CAPS | Oct 13, 1982 | Substantially Equivalent |
| K822543 | CAPD SAFE LOCK TRANSFER SET | Oct 13, 1982 | Substantially Equivalent |
| K822551 | AMP CAPD UNISPIKE AMINISTRATION SET | Oct 13, 1982 | Substantially Equivalent |
| K822544 | SAFE LOCK SEALING CAP L | Oct 13, 1982 | Substantially Equivalent |