FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFE LOCK CATHETER S-3
K Number: K822548
·
Decision Oct 13, 1982
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
82
Applicant Total
30
Review Days
50
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Basic Information
- Device Name
- SAFE LOCK CATHETER S-3
- K Number
- K822548
- 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 24, 1982
- Decision Date
- October 13, 1982
- Product Code
- FKX
- 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 |
|---|---|---|---|
| FKX | System, Peritoneal, Automatic Delivery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKX), ordered by most recent decision date.
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
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CloudCath Peritoneal Dialysis Drain Set Monitoring System
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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 |