Hole Punch
FDA 510(k) K915824 · American Biomaterials Corp.
510(k) numberK915824
Submission
- Device name
- Hole Punch
- Applicant
- American Biomaterials Corp.
The Woodlands, TX, US - Received
- December 30, 1991
- Decision date
- January 29, 1993
- 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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|---|---|---|
| K922455 | Evert-O-Cath CatheterDQO · Traditional | 07/07/1994SE |
| K924725 | American Biomed, Inc. Microsurgical InstrumentsMDM · Traditional | 02/05/1993SE |
| K880371 | Bioglass Dental Endosseous Ridge MaintainerLYC · Traditional | 11/18/1988SE |
| K863796 | Creative Care Systems' IV Start KitLRS · Traditional | 11/28/1986SE |
| K843461 | Bioglass Ossicular Reconstruction ProsthETA · Traditional | 01/09/1985SE |
Questions and answers
When was Hole Punch cleared by the FDA?
Hole Punch (K915824) received a 510(k) decision of Substantially Equivalent on January 29, 1993, 396 days after the submission was received.
What is the product code of K915824?
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.