FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTROCAN SAFETY IV CATHETER
K Number: K982805
·
Decision Jan 14, 1999
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
149
Review Days
157
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
- INTROCAN SAFETY IV CATHETER
- K Number
- K982805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B.Braun Medical, Inc.
- Date Received
- August 10, 1998
- Decision Date
- January 14, 1999
- 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 B.Braun Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253235 | Introcan Safety® Deep Access XL IV Catheter | May 15, 2026 | Substantially Equivalent |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | Jul 24, 2025 | Substantially Equivalent |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | Jul 31, 2024 | Substantially Equivalent |
| K241845 | Introcan Safety® 2 IV Catheter | Jul 26, 2024 | Substantially Equivalent |
| K241385 | Omnifix Syringe NRFit | Jul 13, 2024 | Substantially Equivalent |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | Sep 15, 2023 | Substantially Equivalent |
| K223479 | AQUAbase nX | Aug 16, 2023 | Substantially Equivalent |
| K220756 | Introcan Safety 2 IV Catheter | Jun 23, 2022 | Substantially Equivalent |
| K220626 | Introcan Safety IV Catheter | May 14, 2022 | Substantially Equivalent |
| K213778 | IV Administration Set | Mar 3, 2022 | Substantially Equivalent |