FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER
K Number: K950042
·
Decision Dec 15, 1995
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
47
Applicant Total
9
Review Days
344
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Basic Information
- Device Name
- SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER
- K Number
- K950042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Accurate Surgical Instruments Co.
- Date Received
- January 5, 1995
- Decision Date
- December 15, 1995
- Product Code
- FJS
- 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 |
|---|---|---|---|
| FJS | Catheter, Peritoneal, Long-Term Indwelling | FDA class 2 | Gastroenterology, Urology |
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PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
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FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Accurate Surgical Instruments Co.
| K Number | Device Name | ||
|---|---|---|---|
| K920515 | INSERTION | May 4, 1992 | Substantially Equivalent |
| K910786 | TROCAR (FALLER STYLET) | Sep 19, 1991 | Substantially Equivalent |
| K910785 | TITANIUM CATHETER EXTENDER | Aug 22, 1991 | Substantially Equivalent |
| K910787 | TITANIUM CONNECTOR (2 PART) | Aug 15, 1991 | Substantially Equivalent |
| K862046 | SWAN-NECK PERITONEAL DIALYSIS CATHETERS | Jun 19, 1986 | Substantially Equivalent |
| K850214 | STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN | Jul 26, 1985 | Substantially Equivalent |
| K813488 | CATHETER REGULAR | Dec 31, 1981 | Substantially Equivalent |
| K813487 | CATHETER BUBBLE STAND | Dec 31, 1981 | Substantially Equivalent |