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FDA 510(k)

NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH

K-Number: K900509 · 1990-12-14

ApplicantMedical Latex Corp.
Decision Date1990-12-14
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH is the device name listed in this FDA 510(k) record. The listed applicant is Medical Latex Corp.. It received FDA 510(k) clearance on 1990-12-14 under 510(k) number K900509. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH?

NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH is a medical device that received FDA 510(k) clearance on 1990-12-14. The listed applicant is Medical Latex Corp.. The 510(k) number is K900509.

When did NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH receive FDA 510(k) clearance?

NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH received FDA 510(k) clearance on 1990-12-14, under 510(k) number K900509.

Who is the listed applicant for NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH?

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

What is the FDA product code for NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH?

The FDA product code for NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH is KOD.

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Other records listing Medical Latex 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.

K900561GLOVEX LATEX EXAMINATION GLOVES

Related Devices (Code: KOD)

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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.

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