FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T3
K Number: K123292
·
Decision Jun 11, 2013
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
11
Applicant Total
40
Review Days
232
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Basic Information
- Device Name
- T3
- K Number
- K123292
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcomp
- Date Received
- October 22, 2012
- Decision Date
- June 11, 2013
- Product Code
- NIE
- 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 |
|---|---|---|---|
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NIE), ordered by most recent decision date.
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Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
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POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
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FDA Class 2
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Other Clearances by Medcomp
| K Number | Device Name | ||
|---|---|---|---|
| K130889 | SPLIT CATH RG | Apr 28, 2014 | Unknown |
| 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 |
| K081904 | PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) | Sep 23, 2008 | Substantially Equivalent |