FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PICC-FIX
K Number: K911070
·
Decision Jul 5, 1991
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
63
Applicant Total
9
Review Days
116
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
- PICC-FIX
- K Number
- K911070
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5210
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sorex Medical
- Date Received
- March 11, 1991
- Decision Date
- July 5, 1991
- Product Code
- KMK
- 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 |
|---|---|---|---|
| KMK | Device, Intravascular Catheter Securement | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMK), ordered by most recent decision date.
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
FDA 510(k)
FDA Class 1
·General Hospital
A P HARNESS
FDA 510(k)
FDA Class 1
·General Hospital
MULTI-PURPOSE MEDICAL TUBE HOLDER
FDA 510(k)
FDA Class 1
·General Hospital
SECURE-SITE
FDA 510(k)
FDA Class 1
·General Hospital
STATLOCK CV
FDA 510(k)
FDA Class 1
·General Hospital
IV START KITS
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Sorex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K923843 | FOGLESS | Mar 25, 1994 | Substantially Equivalent |
| K913036 | PLUME MASTER | Sep 6, 1991 | Substantially Equivalent |
| K911150 | SOREX SAFE-AIR | Jun 28, 1991 | Substantially Equivalent |
| K910315 | PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K | Apr 5, 1991 | Unknown |
| K905572 | EDLICH WOUND MANAGEMENT TRAY | Mar 12, 1991 | Unknown |
| K903740 | TRACH-EZE | Dec 6, 1990 | Substantially Equivalent |
| K902410 | MEDICAL PROCEDURE TRAY | Nov 20, 1990 | Unknown |
| K885136 | GRAFT GUARD | Feb 6, 1989 | Substantially Equivalent |