FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
K Number: K121848
·
Decision Sep 21, 2012
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
63
Review Days
88
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Basic Information
- Device Name
- SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
- K Number
- K121848
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Medical Components, Inc.
- Date Received
- June 25, 2012
- Decision Date
- September 21, 2012
- 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 |
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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 |
| K132880 | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE | Jan 8, 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 |
| K120281 | DIGNITY POWER INJECTABLE TITANIUM PORT | Sep 17, 2012 | Substantially Equivalent |