FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATH-SEAL
K Number: K935077
·
Decision Jun 7, 1994
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
21
Review Days
228
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Basic Information
- Device Name
- CATH-SEAL
- K Number
- K935077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Universal Medical Instrument Corp.
- Date Received
- October 22, 1993
- Decision Date
- June 7, 1994
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Universal Medical Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K962180 | CATH SEAL | Nov 7, 1996 | 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 |
| K842259 | PCI W/CATH-SEAL SIDE FLOW FITTING | Aug 1, 1984 | Substantially Equivalent |