Powerglide Midline Catheter
FDA 510(k) K121073 · C.R. Bard, Inc.
510(k) numberK121073
Submission
- Device name
- Powerglide Midline Catheter
- Applicant
- C.R. Bard, Inc.
Salt Lake Ciy,, UT, US - Received
- April 9, 2012
- Decision date
- June 1, 2012
- 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
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| 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 |
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| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
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Questions and answers
When was Powerglide Midline Catheter cleared by the FDA?
Powerglide Midline Catheter (K121073) received a 510(k) decision of Substantially Equivalent on June 1, 2012, 53 days after the submission was received.
What is the product code of K121073?
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.