Churchill-Cath
FDA 510(k) K872585 · Churchill Corp.
510(k) numberK872585
Submission
- Device name
- Churchill-Cath
- Applicant
- Churchill Corp.
Langhorne, PA, US - Received
- July 1, 1987
- Decision date
- October 15, 1987
- 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 |
|---|---|---|
| K880051 | Enteral Bag/SetKNT · Traditional | 04/14/1988SE |
| K880026 | Churchill 0.22 Micron Liquid Compact Filter SetsFPB · Traditional | 04/14/1988SE |
| K880025 | Churchill 0.22 Micron Liquid Filter SetsFPB · Traditional | 04/14/1988SE |
| K880027 | Churchill 1.2 Micron Liquid Filter SetFPB · Traditional | 04/13/1988SE |
| K870395 | Churchill Parenteral Nutrition Bag - EvaKPE · Traditional | 10/15/1987SE |
| K872124 | Churchill Albumin IV Administration SetFPA · Traditional | 10/13/1987SE |
| K872123 | Churchill TPN Administration SetFPA · Traditional | 10/09/1987SE |
| K872043 | Churchill Inter-Cardiac SuckerDWF · Traditional | 09/30/1987SE |
| K871084 | Nitroglycerine Pump SetFRN · Traditional | 07/16/1987SE |
| K871732 | Churchill-H Vented IV Set W/Metering ChambersFPA · Traditional | 06/15/1987SE |
Questions and answers
When was Churchill-Cath cleared by the FDA?
Churchill-Cath (K872585) received a 510(k) decision of Substantially Equivalent on October 15, 1987, 106 days after the submission was received.
What is the product code of K872585?
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.