510(k) K912645 ยท GBS Catheter, Ventricular, General & Plastic Surgery
ATRIUMS PDR THORACIC CATHETER
| Applicant | Atrium Medical Corp., Hollis NH, US |
| Decision | Substantially Equivalent, Sep 13, 1991 |
| Received | Jun 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912645
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9016,
Size (Fr) 16,
# Eyelets 4,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9020,
Size (Fr) 20,
# Eyelets 4,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9024,
Size (Fr) 24,
# Eyelets 5,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9028,
Size (Fr) 28,
# Eyelets 6,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9032,
Size (Fr) 32,
# Eyelets 6,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9036,
Size (Fr) 36,
# Eyelets 6,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9040,
Size (Fr) 40,
# Eyelets 6,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9116,
Size (Fr) 16,
# Eyelets 4,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9120,
Size (Fr) 20,
# Eyelets 4,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9124,
Size (Fr) 24,
# Eyelets 4,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9128,
Size (Fr) 28,
# Eyelets 5,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9132,
Size (Fr) 32,
# Eyelets 5,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip,
Atrium Code # 9136,
Size (Fr) 36,
# Eyelets 5,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation ATP HydraGlide Trocar - Includes Tapered ATP Stylet,
Atrium Code # 9408,
Size (Fr) 8,
# Eyelets 2,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation ATP HydraGlide Trocar - Includes Tapered ATP Stylet,
Atrium Code # 9420,
Size (Fr) 20,
# Eyelets 2,
10 per case Terminated |
GBS | None listed |
| Aug 14, 2008 | Atrium Medical Corporation ATP HydraGlide Trocar - Includes Tapered ATP Stylet,
Atrium Code # 9428,
Size (Fr) 28,
# Eyelets 2,
10 per case Terminated |
GBS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.