FDA 510(k)
Substantially Equivalent
🇺🇸 United States
UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE
K Number: K860168
·
Decision Feb 19, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
21
Review Days
33
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
- UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE
- K Number
- K860168
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Universal Medical Instrument Corp.
- Date Received
- January 17, 1986
- Decision Date
- February 19, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Universal Medical Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K962180 | CATH SEAL | Nov 7, 1996 | Substantially Equivalent |
| K935077 | CATH-SEAL | Jun 7, 1994 | Substantially Equivalent |
| K897128 | UMI BRAIDED CATHETER CONNECTOR | Mar 1, 1990 | Substantially Equivalent |
| K881796 | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE | Jul 26, 1988 | Substantially Equivalent |
| K863178 | UMI STEERABLE TORQUE GUIDE WIRE | Sep 19, 1986 | Substantially Equivalent |
| K861984 | UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO | Aug 5, 1986 | Substantially Equivalent |
| K851088 | UMI ANGIOGRAPHIC CATHETER | May 16, 1985 | Substantially Equivalent |
| K850820 | PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID | Apr 10, 1985 | Substantially Equivalent |
| K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | Jan 31, 1985 | Substantially Equivalent |
| K842259 | PCI W/CATH-SEAL SIDE FLOW FITTING | Aug 1, 1984 | Substantially Equivalent |