FDA 510(k)

P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM

K-Number: K992880 · 1999-10-19

Decision Date1999-10-19

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1999-10-19 under 510(k) number K992880. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM?

P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1999-10-19. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K992880.

When did P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM receive FDA 510(k) clearance?

P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM received FDA 510(k) clearance on 1999-10-19, under 510(k) number K992880.

Who is the listed applicant for P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM?

The FDA 510(k) record lists Sims Deltec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM?

The FDA product code for P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM is LJT.

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Other records listing Sims Deltec, Inc. as applicant

K010426PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER K000842CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM K000942CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 K994216PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM K992697PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM K991599CADD ADMINISTRATION SET

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Related Devices (Code: LJT)

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Official Source

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