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FDA 510(k)

CATHETER MOUNTS -- MODIFICATION

K-Number: K921511 · 1992-06-17

ApplicantIntersurgical, Inc.
Decision Date1992-06-17
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CATHETER MOUNTS -- MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Intersurgical, Inc.. It received FDA 510(k) clearance on 1992-06-17 under 510(k) number K921511. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER MOUNTS -- MODIFICATION?

CATHETER MOUNTS -- MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-06-17. The listed applicant is Intersurgical, Inc.. The 510(k) number is K921511.

When did CATHETER MOUNTS -- MODIFICATION receive FDA 510(k) clearance?

CATHETER MOUNTS -- MODIFICATION received FDA 510(k) clearance on 1992-06-17, under 510(k) number K921511.

Who is the listed applicant for CATHETER MOUNTS -- MODIFICATION?

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

What is the FDA product code for CATHETER MOUNTS -- MODIFICATION?

The FDA product code for CATHETER MOUNTS -- MODIFICATION is BZA.

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Other records listing Intersurgical, Inc. 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.

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Related Devices (Code: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.K954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, 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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