FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MEDCOMP SC4
K Number: K022678
·
Decision Feb 24, 2003
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
40
Review Days
196
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MEDCOMP SC4
- K Number
- K022678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Medcomp
- Date Received
- August 12, 2002
- Decision Date
- February 24, 2003
- Product Code
- MSD
- 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 |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSD), ordered by most recent decision date.
Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
End Cap
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GlidePath Retro Long-Term Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GlidePath 13F Long-Term Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Pristine Long-Term Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GlidePath 7.5F Long-Term Dialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Medcomp
| K Number | Device Name | ||
|---|---|---|---|
| K130889 | SPLIT CATH RG | Apr 28, 2014 | Unknown |
| K123292 | T3 | Jun 11, 2013 | Substantially Equivalent |
| K102966 | 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC | Dec 21, 2010 | Substantially Equivalent |
| K091954 | MICRO-STICK SET | Jan 8, 2010 | Substantially Equivalent |
| K092347 | PRO-PICC CT | Sep 16, 2009 | Substantially Equivalent |
| K091953 | PRO-PICC | Sep 16, 2009 | Substantially Equivalent |
| K090394 | VALVED TEARWAY INTRODUCER | Sep 1, 2009 | Substantially Equivalent |
| K091586 | VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN | Jul 23, 2009 | Substantially Equivalent |
| K091466 | 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 | Jun 17, 2009 | Substantially Equivalent |
| K081775 | THE MEDCOMP .010 VASCULAR GUIDEWIRES | Mar 25, 2009 | Substantially Equivalent |