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FDA 510(k)

INTRODUCER SHEATH

K-Number: K001328 · 2000-07-17

ApplicantNovasys Medical, Inc.
Decision Date2000-07-17
Product CodeFEC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Novasys Medical, Inc.. It received FDA 510(k) clearance on 2000-07-17 under 510(k) number K001328. The device is classified under product code FEC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRODUCER SHEATH?

INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2000-07-17. The listed applicant is Novasys Medical, Inc.. The 510(k) number is K001328.

When did INTRODUCER SHEATH receive FDA 510(k) clearance?

INTRODUCER SHEATH received FDA 510(k) clearance on 2000-07-17, under 510(k) number K001328.

Who is the listed applicant for INTRODUCER SHEATH?

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

What is the FDA product code for INTRODUCER SHEATH?

The FDA product code for INTRODUCER SHEATH is FEC.

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Other records listing Novasys Medical, 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.

K042132NOVASYS TRANSURETHRAL RF SYSTEMK013730ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIESK001150ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEEK001151ELECTROSURGICAL ELECTRODE FAMILY

Related Devices (Code: FEC)

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.

K760183OBTURATOR, DEFLECTINGV. Mueller O.V. Baxter Healthcare Corp.K760172OBTURATOR, VISUALV. Mueller O.V. Baxter Healthcare Corp.

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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