FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
K Number: K100282
·
Decision Feb 26, 2010
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
21
Review Days
25
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
- TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
- K Number
- K100282
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Corp.
- Date Received
- February 1, 2010
- Decision Date
- February 26, 2010
- Product Code
- FOZ
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOZ), ordered by most recent decision date.
Introcan Safety® Deep Access XL IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
BD Insyte IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
FDA 510(k)
FDA Class 2
·General Hospital
SURFLO Hybria Closed System Safety IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
Polyshield Safety IV Catheters
FDA 510(k)
FDA Class 2
·General Hospital
BD Saf-T-Intima Subcutaneous Catheter System
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Terumo Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K092372 | HEARTRAIL III GUIDING CATHETER | Sep 11, 2009 | Substantially Equivalent |
| K091417 | SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A | May 22, 2009 | Substantially Equivalent |
| K090973 | TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) | May 1, 2009 | Substantially Equivalent |
| K073474 | CAPIOX CIRCUIT CONNECTORS | Mar 5, 2008 | Substantially Equivalent |
| K071572 | CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER | Jul 23, 2007 | Substantially Equivalent |
| K071494 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER | Jul 16, 2007 | Substantially Equivalent |
| K071075 | TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A | May 25, 2007 | Substantially Equivalent |
| K040783 | FOUNDATION | Oct 13, 2004 | Substantially Equivalent |
| K040210 | CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR | Mar 3, 2004 | Substantially Equivalent |
| K033681 | GLIDESHEATH | Dec 11, 2003 | Substantially Equivalent |