FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER, EMBOLECTOMY, UMI
K Number: K770569
·
Decision Apr 5, 1977
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
73
Applicant Total
21
Review Days
11
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Basic Information
- Device Name
- CATHETER, EMBOLECTOMY, UMI
- K Number
- K770569
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Universal Medical Instrument Corp.
- Date Received
- March 25, 1977
- Decision Date
- April 5, 1977
- Product Code
- DXE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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Merlin Aspiration System
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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 |
| K860168 | UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE | Feb 19, 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 |