Sodium Chloride Solution
FDA 510(k) K903347 · Superior Healthcare Group, Inc.
510(k) numberK903347
Submission
- Device name
- Sodium Chloride Solution
- Applicant
- Superior Healthcare Group, Inc.
Cumberland, RI, US - Received
- July 25, 1990
- Decision date
- December 13, 1990
- 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 |
|---|---|---|
| K925530 | Instrument WarmerFMS · Traditional | 06/18/1993SE |
| K924764 | Overtube for Endscopic LigatorMNK · Traditional | 03/15/1993SE |
| K905755 | Non-Sterile Patient Examination GlovesLYY · Traditional | 03/08/1991SE |
| K904216 | Sterile Water Solution Catalog # 10000JOL · Traditional | 11/16/1990SE |
| K903340 | Sterile Urethral Catheter Procedure KitsFCM · Traditional | 10/04/1990SESD |
| K896321 | No. 34100 - 8 FR & No. 34400 - 14 FR Closed Trach.BSY · Traditional | 11/13/1989SE |
| K894676 | Sterile Latex Exam GlovesLYY · Traditional | 08/17/1989SE |
| K891445 | Latex Examination GlovesLYY · Traditional | 08/09/1989SE |
| K892426 | No. 86500 - Endoscopic Jet WasherOCX · Traditional | 06/22/1989SE |
| K885339 | Flow Thru 16,18,20,22 FR Replace. Gastro Tube KitKNT · Traditional | 03/01/1989SE |
Questions and answers
When was Sodium Chloride Solution cleared by the FDA?
Sodium Chloride Solution (K903347) received a 510(k) decision of Substantially Equivalent on December 13, 1990, 141 days after the submission was received.
What is the product code of K903347?
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.