FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
K Number: K132880
·
Decision Jan 8, 2014
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
63
Review Days
117
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Basic Information
- Device Name
- MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
- K Number
- K132880
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Components, Inc.
- Date Received
- September 13, 2013
- Decision Date
- January 8, 2014
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Medical Components, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | Aug 12, 2025 | Substantially Equivalent |
| K141633 | PRO-PICC WITH VALVE TECHNOLOGY | Sep 29, 2014 | Substantially Equivalent |
| K131687 | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET | Aug 16, 2013 | Substantially Equivalent |
| K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER | Aug 15, 2013 | Substantially Equivalent |
| K130923 | 5F DIGNITY CT TITANIUM PORT | Jul 31, 2013 | Substantially Equivalent |
| K124046 | VALVED TEARAWAY INTRODUCER GENERATION II | Jun 3, 2013 | Substantially Equivalent |
| K123617 | 3F PRO-PICC | May 15, 2013 | Substantially Equivalent |
| K122423 | VASU-PICC | Dec 12, 2012 | Substantially Equivalent |
| K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM | Sep 21, 2012 | Unknown |
| K120281 | DIGNITY POWER INJECTABLE TITANIUM PORT | Sep 17, 2012 | Substantially Equivalent |