Clinicath Polyflow Polyurethane Peripherally Inserted Catheters
FDA 510(k) K984055 · Sims Deltec, Inc.
510(k) numberK984055
Submission
- Device name
- Clinicath Polyflow Polyurethane Peripherally Inserted Catheters
- Applicant
- Sims Deltec, Inc.
St. Paul, MN, US - Received
- November 13, 1998
- Decision date
- January 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code FOZ
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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.
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|---|---|---|
| K010426 | Proport Plastic Venous Implantable Access Systems Pre-Assembled with Silicone CatheterLJT · Traditional | 03/08/2001SE |
| K000842 | Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemFRN · Traditional | 06/08/2000SE |
| K000942 | Cadd Checkvalve Administration Set, Model 21-7090FPA · Traditional | 04/27/2000SE |
| K994216 | Plastic Port Implantable Venous Access SystemLJT · Traditional | 01/27/2000SE |
| K992697 | Port-A-Cath II Trans-Arterial Percutaneous SystemLJT · Traditional | 11/18/1999SE |
| K992880 | P.A.S. Port Elite Implantable Venous Access SystemLJT · Traditional | 10/19/1999SE |
| K991599 | Cadd Administration SetFPA · Traditional | 06/15/1999SE |
| K991301 | Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-On Anti-Siphon…FPA · Traditional | 06/09/1999SE |
| K991255 | Cadd-Tpn Administration Set, Model 21-7071FPA · Traditional | 06/09/1999SE |
| K990083 | Cadd Administration Set, Cadd 250ML Flexible Medication Reservoir, Modified Securit…FPA · Traditional | 02/12/1999SE |
Questions and answers
When was Clinicath Polyflow Polyurethane Peripherally Inserted Catheters cleared by the FDA?
Clinicath Polyflow Polyurethane Peripherally Inserted Catheters (K984055) received a 510(k) decision of Substantially Equivalent on January 29, 1999, 77 days after the submission was received.
What is the product code of K984055?
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.