Product code KPK— General, Plastic Surgery

FDA has cleared 6 devices under product code KPK between 1977 and 1998, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19981 clearance
• 19891 clearance
• 19871 clearance
• 19861 clearance
• 19801 clearance
• 19771 clearance

• Voss Medical Products1 clearance
• Scanlan Intl., Inc.1 clearance
• Med-Edge, Inc.1 clearance
• Cook, Inc.1 clearance
• Cardio-Surgical, Inc.1 clearance
• C.R. Bard, Inc.1 clearance

• K971966 — CORONARY VEIN GRAFT TAG MARKERMed-Edge, Inc.·1998-01-26
• K895369 — VOSS GRAFT MARKERVoss Medical Products·1989-09-27
• K864919 — SCANLAN (TM) VEIN/GRAFT HOLDERScanlan Intl., Inc.·1987-01-12
• K864101 — COOK (R) VEIN GRAFT RING MARKERSCook, Inc.·1986-10-30
• K801637 — FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.C.R. Bard, Inc.·1980-08-27
• K770802 — MARKERS, STAINLESS STEELCardio-Surgical, Inc.·1977-06-27