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510(k) K913101

PETERS CARDIOFLON(TM) SUTURE by Promedica Products, Inc. — Product Code GAS

K913101 is an FDA 510(k) premarket notification submitted by Promedica Products, Inc. for the device "PETERS CARDIOFLON(TM) SUTURE". The FDA issued a decision of Substantially Equivalent on August 12, 1992. The device falls under product code GAS (Suture, Nonabsorbable, Synthetic, Polyester), a Class II device regulated under 21 CFR 878.5000. Promedica Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1992
Date Received
July 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyester
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Promedica Products, Inc.

  • K913102 — PETERS CARDIONYL(TM) SUTURE (August 3, 1992)
  • K892768 — PATIENT EXAMINATION GLOVES (POLY) (June 14, 1989)
  • K883412 — THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) (February 8, 1989)
  • K882882 — C-MASK (August 10, 1988)
  • K882883 — C-MASK(FLAT) (August 10, 1988)

Other clearances for product code GAS

  • K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK (November 24, 2020)
  • K203081 — RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (November 24, 2020)
  • K091018 — ARTHREX BIOWIRE (July 30, 2010)
  • K002261 — MR-III (October 23, 2000)
  • K953128 — SUTURE CORD (February 9, 1996)
  • K923161 — BRAIDED POLYESTER SUTURE MATERIAL (December 30, 1992)
  • K915089 — MITEK QUICKANCHOR(TM), MODIFICATION (February 3, 1992)
  • K915081 — MITEK SNAP PAK(TM), MODIFICATION (January 31, 1992)
  • K903175 — ADVANCE SUTURE NONABSORBABLE DACRON SUTURE (July 26, 1991)
  • K905285 — IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES (February 11, 1991)

FDA data resources