FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMO-CATH II KIDNEY DIALYSIS CATHETER
K Number: K801966
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
63
Review Days
38
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
- HEMO-CATH II KIDNEY DIALYSIS CATHETER
- K Number
- K801966
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Components, Inc.
- Date Received
- August 19, 1980
- Decision Date
- September 26, 1980
- Product Code
- FIE
- 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 |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
JMS CAVEO A.V. Fistula Needle Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JMS Harmony A.V. Fistula Needle Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| 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 |