Catheter, Intravascular
FDA 510(k) K881976 · Primrose Medical, Inc.
510(k) numberK881976
Submission
- Device name
- Catheter, Intravascular
- Applicant
- Primrose Medical, Inc.
Woburn, MA, US - Received
- May 11, 1988
- Decision date
- August 4, 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 |
|---|---|---|
| K884715 | Achelasia Balloon DialatorKNQ · Traditional | 09/29/1989SE |
| K884714 | Biliary DialatorFGE · Traditional | 09/29/1989SE |
| K884713 | Colonic Balloon DialatorsFFP · Traditional | 09/29/1989SE |
| K884711 | Urethral and Ureteral Balloon DilatatorsEZN · Traditional | 09/29/1989SE |
| K884712 | Esophageal and Pyloric Balloon DialatorsKNQ · Traditional | 09/08/1989SE |
| K884709 | Endoscopes & Access.(Sclerotherapy/Transbronchial)ODD · Traditional | 09/08/1989SE |
| K883420 | Lancet, BloodFMK · Traditional | 08/26/1988SE |
| K881977 | Pressure InfusorKZD · Traditional | 07/29/1988SE |
| K881975 | Set, IntravascularFPA · Traditional | 07/29/1988SE |
| K881978 | Enteral Feeding TubesKNT · Traditional | 07/13/1988SE |
Questions and answers
When was Catheter, Intravascular cleared by the FDA?
Catheter, Intravascular (K881976) received a 510(k) decision of Substantially Equivalent on August 4, 1988, 85 days after the submission was received.
What is the product code of K881976?
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.