FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
FLEX-NECK ARC CATHETER
K Number: K070730
·
Decision Jul 3, 2007
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
47
Applicant Total
6
Review Days
110
Basic Information
- Device Name
- FLEX-NECK ARC CATHETER
- K Number
- K070730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- MEDIGROUP, INC.
- Date Received
- March 15, 2007
- Decision Date
- July 3, 2007
- 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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Other Clearances by MEDIGROUP, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K120130 | FALLER TROCAR | May 21, 2012 | Substantially Equivalent |
| K071167 | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 | Aug 31, 2007 | Unknown |
| K060897 | EMBEDDING TOOL, MODEL TE-1000 | Jul 18, 2006 | Substantially Equivalent |
| K031351 | FLEX-NECK PD CATHETER, INFANT | Sep 17, 2003 | Substantially Equivalent |
| K974570 | PERITONEAL DIALYSIS CATHETER CONNECTOR | Feb 27, 1998 | Substantially Equivalent |