Picc Line Kit
FDA 510(k) K952256 · Medi-Flex Hospital Products, Inc.
510(k) numberK952256
Submission
- Device name
- Picc Line Kit
- Applicant
- Medi-Flex Hospital Products, Inc.
El Paso, TX, US - Received
- May 15, 1995
- Decision date
- July 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
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|---|---|---|---|
| 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 |
|---|---|---|
| K970441 | K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch LengthFPX · Traditional | 05/09/1997SE |
| K962740 | Dermistick Sepp APPLICATOR(200 CT)/(40 CT) 260640/260641KMF · Traditional | 09/06/1996SE |
| K952201 | Port-A-Cath Access KitFMF · Traditional | 10/04/1995SE |
| K952416 | Tracheostomy Care KitBTO · Traditional | 08/09/1995SESK |
| K952007 | Adherol Sepp ApplicatorFRO · Traditional | 06/08/1995SE |
| K934790 | Sepp Adhesive RemoverKOX · Traditional | 03/11/1994SE |
| K923516 | Compound Benzoin Tincture Usp SeppKMF · Traditional | 01/25/1994SE |
| K920399 | Compound Benzoin Tincture Usp FreppKMF · Traditional | 01/25/1994SE |
| K930196 | Cepti-Seal I.V. Prep KitLRS · Traditional | 07/02/1993SEKD |
| K921347 | Cepti-Seal Dressing Change Kit for Venous CatheterMCY · Traditional | 01/08/1993SEKD |
Questions and answers
When was Picc Line Kit cleared by the FDA?
Picc Line Kit (K952256) received a 510(k) decision of Substantially Equivalent on July 31, 1995, 77 days after the submission was received.
What is the product code of K952256?
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.