FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERIPHERALLY INSERTED CENTRAL CATHETER
K Number: K001874
·
Decision Sep 25, 2000
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
38
Review Days
97
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Basic Information
- Device Name
- PERIPHERALLY INSERTED CENTRAL CATHETER
- K Number
- K001874
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Utah Medical Products, Inc.
- Date Received
- June 20, 2000
- Decision Date
- September 25, 2000
- Product Code
- LJS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | FDA class 2 | General Hospital |
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| K Number | Device Name | ||
|---|---|---|---|
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| K101535 | BT-CATH | Jan 11, 2011 | Substantially Equivalent |
| K063611 | SALINE/ CONTRAST MEDIA INFUSION CATHETER | May 23, 2007 | Substantially Equivalent |
| K000974 | FOWLER ENDOCURETTE, MODEL CUR-XXX | May 23, 2000 | Substantially Equivalent |
| K965245 | TBD | Jul 3, 1997 | Substantially Equivalent |
| K970077 | LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) | May 23, 1997 | Substantially Equivalent |
| K955663 | ABC IN-LINE BLOOD SAMPLING KIT | Mar 17, 1997 | Substantially Equivalent |
| K964526 | LIBERTY RECTAL PELVIC FLOOR EXERCISER | Feb 10, 1997 | Substantially Equivalent |
| K961424 | INTRAN 500 | Jul 10, 1996 | Substantially Equivalent |