FDA 510(k)

SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH

K-Number: K983511 · 1999-06-08

Decision Date1999-06-08

Product CodeMPB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 1999-06-08 under 510(k) number K983511. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH?

SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH is a medical device that received FDA 510(k) clearance on 1999-06-08. The listed applicant is Medical Components, Inc.. The 510(k) number is K983511.

When did SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH receive FDA 510(k) clearance?

SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH received FDA 510(k) clearance on 1999-06-08, under 510(k) number K983511.

Who is the listed applicant for SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH?

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

What is the FDA product code for SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH?

The FDA product code for SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH is MPB.

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Other records listing Medical Components, Inc. as applicant

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Related Devices (Code: MPB)

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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.