FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON
K Number: K030270
·
Decision Apr 11, 2003
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
297
Applicant Total
37
Review Days
74
Basic Information
- Device Name
- 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON
- K Number
- K030270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDCOMP
- Date Received
- January 27, 2003
- Decision Date
- April 11, 2003
- Product Code
- LJS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJS), ordered by most recent decision date.
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
FDA 510(k)
FDA Class 2
·General Hospital
PM2+ System and SmartPICC Stylet
FDA 510(k)
FDA Class 2
·General Hospital
pilot TLS
FDA 510(k)
FDA Class 2
·General Hospital
Neonav ECG Tip Location System
FDA 510(k)
FDA Class 2
·General Hospital
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)
FDA 510(k)
FDA Class 2
·General Hospital
PM2 System and ECGuide Connector
FDA 510(k)
FDA Class 2
·General Hospital
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 |
| K091953 | PRO-PICC | Sep 16, 2009 | Substantially Equivalent |
| K092347 | PRO-PICC CT | 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 |