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FDA 510(k)

INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER

K-Number: K921751 · 1993-07-07

ApplicantStrato Medical Corp.
Decision Date1993-07-07
Product CodeLJS
Advisory CommitteeHO
DecisionUnknown

Device Summary

INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Strato Medical Corp.. It received FDA 510(k) clearance on 1993-07-07 under 510(k) number K921751. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER?

INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER is a medical device that received FDA 510(k) clearance on 1993-07-07. The listed applicant is Strato Medical Corp.. The 510(k) number is K921751.

When did INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER receive FDA 510(k) clearance?

INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER received FDA 510(k) clearance on 1993-07-07, under 510(k) number K921751.

Who is the listed applicant for INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER?

The FDA 510(k) record lists Strato Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER?

The FDA product code for INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER is LJS.

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Other records listing Strato Medical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945956STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMSK946250STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMSK942848STRATO MEDICAL LIFEPORT LPS 7515K934518STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEMK932509STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORTK933884STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM

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Related Devices (Code: LJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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