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FDA 510(k)

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

K-Number: K952884 · 1996-02-21

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1996-02-21
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. It received FDA 510(k) clearance on 1996-02-21 under 510(k) number K952884. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER?

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1996-02-21. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K952884.

When did NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER received FDA 510(k) clearance on 1996-02-21, under 510(k) number K952884.

Who is the listed applicant for NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER?

The FDA 510(k) record lists Meadox Medicals, Div. Boston Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER?

The FDA product code for NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER is LIT.

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Other records listing Meadox Medicals, Div. Boston Scientific 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.

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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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