Vitaaccess (TM) Catheter Introducer System
FDA 510(k) K872998 · Vitaphore Corp.
510(k) numberK872998
Submission
- Device name
- Vitaaccess (TM) Catheter Introducer System
- Applicant
- Vitaphore Corp.
San Carlos, CA, US - Received
- August 3, 1987
- Decision date
- March 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914579 | Silver Foam Wound DressingFRO · Traditional | 02/21/1992SE |
| K913148 | Collagen Shield for Acute CareMOE · Traditional | 10/15/1991SE |
| K895920 | Vitapatch Pin Protection Device for PercutaneousKGX · Traditional | 06/06/1991SE |
| K902558 | Collagen Shield for Acute CareMOE · Traditional | 08/17/1990SE |
| K891993 | Collagen NeurospongeHBA · Traditional | 03/23/1990SE |
| K896455 | Vitachoice Wound DressingKGX · Traditional | 02/15/1990SE |
| K896046 | Vitapatch Cath. Securement Device W/ChlorhexidineKMK · Traditional | 01/11/1990SE |
| K895993 | Vitapatch Antimicrobial Catheter Securement DeviceKMK · Traditional | 01/11/1990SE |
| K890435 | Vitaaccess Catheter Introducer KitFOZ · Traditional | 03/29/1989SESD |
| K882100 | Vitacuff(R) Percutaneous Infect. Control KitLJS · Traditional | 07/13/1988SE |
Questions and answers
When was Vitaaccess (TM) Catheter Introducer System cleared by the FDA?
Vitaaccess (TM) Catheter Introducer System (K872998) received a 510(k) decision of Substantially Equivalent on March 24, 1988, 234 days after the submission was received.
What is the product code of K872998?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.