Peters Cardioflon(Tm) Suture
FDA 510(k) K913101 · Promedica Products, Inc.
510(k) numberK913101
Submission
- Device name
- Peters Cardioflon(Tm) Suture
- Applicant
- Promedica Products, Inc.
Newport Beach, CA, US - Received
- July 12, 1991
- Decision date
- August 12, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAS – Suture, Nonabsorbable, Synthetic, Polyester
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD…GAS · Special | Lsi Solutions, Inc. | 11/24/2020SE |
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureGAS · Special | Lsi Solutions | 11/24/2020SE |
| K091018 | Arthrex BiowireGAS · Traditional | Arthrex, Inc. | 07/30/2010SE |
| K002261 | Mr-IiiGAS · Traditional | Smith & Nephew, Inc. | 10/23/2000SE |
| K953128 | Suture CordGAS · Traditional | Phoenix Biomedical Corp. | 02/09/1996SN |
| K923161 | Braided Polyester Suture MaterialGAS · Traditional | Mitek Surgical Products, Inc. | 12/30/1992SE |
| K915089 | Mitek Quickanchor(Tm), ModificationGAS · Traditional | Mitek Surgical Products, Inc. | 02/03/1992SE |
| K915081 | Mitek Snap Pak(Tm), ModificationGAS · Traditional | Mitek Surgical Products, Inc. | 01/31/1992SE |
| K903175 | Advance Suture Nonabsorbable Dacron SutureGAS · Traditional | Advance Suture, Inc. | 07/26/1991SE |
| K905285 | Ifsa Sterile Braided Poly Nonabsor Surg SuturesGAS · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 02/11/1991SE |
More from Internacional Farmaceutica, S.A. DE C.V.
| 510(k) | Device | Decision |
|---|---|---|
| K913102 | Peters Cardionyl(Tm) SutureGAR · Traditional | 08/03/1992SE |
| K892768 | Patient Examination Gloves (Poly)LZA · Traditional | 06/14/1989SE |
| K883412 | The Carpentier Trans-Mitral Ventricular Vent(Tm)DWF · Traditional | 02/08/1989SE |
| K882883 | C-Mask(Flat)FXX · Traditional | 08/10/1988SE |
| K882882 | C-MaskFXX · Traditional | 08/10/1988SE |
Questions and answers
When was Peters Cardioflon(Tm) Suture cleared by the FDA?
Peters Cardioflon(Tm) Suture (K913101) received a 510(k) decision of Substantially Equivalent on August 12, 1992, 397 days after the submission was received.
What is the product code of K913101?
The FDA product code is GAS – Suture, Nonabsorbable, Synthetic, Polyester, a Class II (moderate risk) device regulated under 21 CFR 878.5000.